How to Report Bard PowerPort Injuries and Adverse Health Effects

What Is the Bard PowerPort Device?

The Bard PowerPort device is an implantable port catheter device designed and manufactured by Bard Access Systems Inc. and used to gain access to a patient’s vascular system.

As an implantable port, the Bard PowerPort catheter device gives physicians and other healthcare personnel alternative access for delivering medication and fluids directly into the bloodstream.

Bard PowerPort catheters are surgically implanted in the skin, usually in the chest or upper arm.

During implantation, a surgeon selects a site that’s close to major blood vessels like large veins.

From here, the implantable port is placed on the selected site with the catheter tube inside the selected blood vessel.

The PowerPort implantable port is then sutured securely for added security.

Once the implanted port catheter device is in place, healthcare personnel can administer IV medications into the catheter.

The PowerPort aims to make the medication experience more comfortable for patients since health workers no longer need to look for venous access.

Due to its design, the Bard PowerPort device is useful for a range of conditions.

This device is utilized in various medical conditions such as cancer, chronic kidney disease, HIV/AIDS, and for patients requiring long-term intravenous (IV) therapy.

The catheter body consists of a polyurethane and barium sulfate material called “Chronoflex AL”, which is the topic of the Bard PowerPort Lawsuits.

Bard PowerPort Device Malfunctions

Bard PowerPort catheters are made of polyurethane material called “Chronoflex AL”, comprised of a mixture of polyurethane and barium sulfate.

This material in particular is what may cause a catheter to fracture and migrate.

Barium sulfate particles may break away from the catheter and cause the device to be more susceptible to fracturing and migrating, resulting in serious injuries and complications.

Catheter Migration

Catheter migration is a notable complication associated with Bard PowerPort catheters, characterized by the unintended movement of the catheter from its original placement.

This displacement can lead to significant discomfort, including persistent pain, and may impede the functionality of the port.

More critically, catheter migration can cause harm to nearby tissues and may precipitate other severe complications.

This issue requires immediate medical attention to reposition or replace the catheter, ensuring it does not lead to further health risks or hinder the effectiveness of the intended medical treatments.

Catheter Occlusion

Catheter occlusion can lead to ineffective treatment, discomfort for the patient, and increased risk of blood clots and other vascular system issues.

Catheter occlusion is a serious malfunction in port catheter devices, where a blockage occurs within the catheter.

This blockage can result from various factors, including the accumulation of blood clots, remnants of medications, infections, or tissue growth near the catheter’s tip.

Such occlusions can significantly disrupt the smooth flow of blood or medication, leading to ineffective treatments and patient discomfort.

Moreover, the presence of a catheter occlusion heightens the risk of developing blood clots and other complications within the vascular system that hinder blood flow.

Addressing this issue promptly is crucial to restore the catheter’s functionality and mitigate potential health risks.

Catheter Fracture

A significant and potentially serious complication with Bard PowerPort catheters is catheter fracture.

This occurs when the catheter develops a crack or break, often due to the barium sulfate and polyurethane catheter material.

Catheter fractures can lead to parts of the catheter dislodging and traveling through the bloodstream, posing a significant risk to the patient.

Such incidents can lead to embolism, vessel trauma, or even organ damage if the fragments lodge in critical areas.

Furthermore, a fractured catheter may also compromise the effectiveness of treatments, as it can disrupt the proper administration of medications or other fluids.

Catheter fracture necessitates prompt medical intervention to locate and retrieve the fractured segments and address any resulting complications.

Injuries and Adverse Health Effects From Bard PowerPort Devices

Defective Bard PowerPort devices can cause serious injuries to blood vessels and surrounding tissues.

Below are the injuries and complications associated with fractured or dislodged Bard Powerport implantable port catheters:

• Deep venous thrombosis (DVT)
• Infection
• Severe and persistent pain
• Nerve damage
• Blood vessel damage
• Cardiac arrhythmias

Deep Vein Thrombosis (DVT)

DVT is a serious condition where blood clots form in deep veins, usually in the legs.

Having a central venous catheter like a Bard PowerPort can increase the risk of upper extremity DVT due to the presence of a foreign object in the bloodstream.

If a clot forms and travels to other parts of the body, it can cause life-threatening complications such as pulmonary embolism.

Treating DVT often requires blood thinners and other forms of therapy.

Catheter Infection

Infections at the site of the Bard PowerPort are a significant concern.

Bacteria can enter the body during the implantation procedure or manifest within the port site, leading to localized or even life-threatening infections.

Prompt recognition and treatment with antibiotics are crucial to prevent bloodstream infections and other complications associated with the defective device.

Severe and Persistent Pain

Some patients may experience severe and persistent pain at the site of the Bard PowerPort.

This discomfort can be due to various factors, including nerve irritation, infection, or a faulty Bard PowerPort device.

Since Bard PowerPort implants are long-term, pain at the site can be chronic and significantly affect a patient’s quality of life.

Nerve Damage

A defective or fractured Bard PowerPort device might also lead to nerve damage.

When a venous catheter like a Bard PowerPort device breaks, its fragments can potentially damage surrounding nerves.

The damage can lead to sensations of tingling, numbness, or weakness in the affected area.

Nerve damage can cause discomfort and affect the patient’s mobility.

Damage to Blood Vessels

Fractured and defective PowerPort implantable port catheter devices can also lead to extensive blood vessel damage.

Fragments can end up in the bloodstream and injure blood vessel walls.

Some of these fragments may even lodge themselves near the lungs and heart, resulting in significant chest pain.

Cardiac Arrhythmia

In rare cases, Bard PowerPort devices could lead to serious complications like cardiac arrhythmias.

Cardiac arrhythmias are life-threatening irregularities in heart contractions.

If left untreated, an arrhythmia can lead to cardiac arrest, stroke, and even death.

Cardiac arrhythmias due to Bard catheter failure are tricky to spot since they don’t appear immediately.

On average, heart irregularities occur roughly 90 days after the implant malfunctions.

How To Report Bard PowerPort Injuries

If you’ve experienced any injuries or adverse health effects after being implanted with a Bard PowerPort catheter, you can report your injuries to the U.S. Food and Drugs Administration (FDA).

The FDA allows affected individuals to report their injuries using its Medical Device Report platform.

Below is a step-by-step guide on how you can report your Bard PowerPort implant injuries to the FDA using the Medical Device Report platform.

1. Gather Necessary Documents

Documents proving your injuries are vital when reporting to the FDA.

Some of the documents you’ll need are medical records, treatment records, and a diagnosis.

Your records should contain evidence that you received a Bard PowerPort implant and suffered from the complications associated with it.

2. Fill Out the FDA’s MedWatch Form 3500B

The MedWatch Form 3500B is for consumers and patients who sustained serious injuries due to defective medical devices.

On the adverse event reports form, you should mention the following:

• Adverse effects from using a medical device
• The cause of your adverse event
• The product’s defects that led to your serious injuries

The form is available in English and Spanish.

If you need additional guidance, our attorneys would be happy to assist you.

Contact us at TorHoerman Law if you need guidance on the FDA reporting process and help with your Bard Power Port Lawsuit.

The Importance of Reporting Your Injuries to the FDA

Reporting your injuries may not lead to the same results as if you file a Bard Powerport lawsuit.

However, reporting your injuries to the FDA is important for several reasons.

Patient Safety

Reporting injuries to the FDA helps ensure patient safety.

When adverse events related to medical devices like the Bard PowerPort are reported, it allows the FDA to investigate the issue, identify potential trends, and take necessary actions to prevent further harm to patients.

This information can lead to device recalls, safety alerts, or changes in usage protocols, ultimately safeguarding patients.

Prompting Oversight by the FDA

The FDA relies on post-market surveillance data — including reports of injuries — to monitor the safety and efficacy of medical devices.

These reports provide valuable information for regulatory decision-making.

If a particular device — such as the Bard PowerPort — shows a higher incidence of injuries, the FDA can take regulatory actions to address the problem, including reassessing the device’s approval status or imposing stricter guidelines for its use.

Data Collection for Research

Research findings can inform the design of clinical trials evaluating new medical devices, including next-generation implantable central venous catheters.

Findings can help ensure that new devices are rigorously tested and evaluated for potential risks and benefits.

Initiating Recalls

If reported injuries indicate a serious or widespread problem with a specific batch or model of PowerPort devices, the FDA can initiate recalls.

A recall is an official action to remove a product from the market or correct the problem.

These are often ordered to prevent further harm to patients but only after overseeing bodies like the FDA have received sufficient reports.

Supporting Legal Actions

Reporting PowerPort injuries to the FDA is essential as it establishes patterns of harm, provides official documentation, corroborates patient testimonies, demonstrates manufacturer awareness, and strengthens legal arguments.

These reports may serve as crucial evidence in legal actions and enable the documentation of adverse events and supporting claims of negligence.

By contributing to the body of evidence, FDA medical device reports enhance the credibility of legal cases.

Bard Willfully Underreported the Number of PowerPort-Related Injuries

The Bard PowerPort entered the market through the FDA’s 510(k) process, which allowed it to bypass FDA approval, requiring no more than a premarket notification.

Bard took advantage of the now-closed Alternative Summary Reporting (ASR) program, enabling the company to submit reports on adverse health effects through a private database.

By doing so, Bard shielded these reports from public scrutiny until 2019.

Between 2004 and 2017, Bard only disclosed 1,200 reports about PowerPort adverse events publicly.

In that same time period, around 9,000 reports about PowerPort adverse events were submitted through the ASR program that wasn’t available to the public.

After the ASR program ended, reports of PowerPort complications increased by over 75%.

This development shows the limited transparency and potential gaps in oversight within the medical device approval process.

By underreporting the number of PowerPort-related injuries, the company concealed evidence showing its product’s risks.

Fortunately, the closure of the ASR enabled more claims to surface, displaying the company’s liability and willingness to prioritize profit over patient safety.

What Is the Bard PowerPort Lawsuit?

The Bard PowerPort lawsuits are a collection of legal claims filed by individuals who suffered due to defective PowerPort implants.

The lawsuits claim that Bard Systems Inc. and Beckton Dickinson and Company were negligent in the manufacturing and distribution of defective PowerPort devices.

There are three grounds for the Bard PowerPort lawsuit allegations:

• Design Defects: Plaintiffs argue that the Bard PowerPort device is prone to catheter fractures and migration.
• Failure To Warn: Allegations state that Bard Access Systems, Inc. failed to warn patients and healthcare providers about potential risks associated with its medical devices.
• Strict Liability: Plaintiffs claim that Bard PowerPort devices are inherently dangerous. The product’s risks render the manufacturers strictly liable for any resulting injuries or complications.

The Bard PowerPort MDL (MDL 3081)

Due to the number of cases filed, these were consolidated into multidistrict litigation (MDL) in the U.S. District Court for the District of Arizona.

Judge David G. Campbell oversees MDL 3081, according to the U.S. Judicial Panel for Multidistrict Litigation.

The same court also oversees the litigation for Bard IVC Filters.

Potential Bard PowerPort Settlement Amounts

The Bard PowerPort Lawsuit is in its early stages, and settlement values are still being estimated.

Attorneys project that potential settlement amounts in the Bard PowerPort Lawsuit could range between $10,000 and over $100,000 depending on the litigation process and later down the line, an individual’s damages and circumstances. 

These projections are by no means a guarantee of financial compensation in the Bard PowerPort Lawsuit.

TorHoerman Law: Your Bard PowerPort Lawyers

People who have been injured by the Bard PowerPort catheter device may be eligible to file claims against the medical device manufacturer.

Our attorneys are speaking to people about injuries related to the potentially defective Bard PowerPort device and assessing their eligibility to join the Bard PowerPort Lawsuits filed against the manufacturer(s).

If you or a loved one used a Bard PowerPort device and subsequently suffered serious injuries, you may be eligible to file a Bard PowerPort Lawsuit.

Contact TorHoerman Law for a free consultation.

You can also use the chatbot on this page to find out if you’re eligible to file a Bard PowerPort Lawsuit instantly.

Our law firm is committed to helping people seek justice, and our attorneys have decades of experience handling product liability lawsuits against large corporations.

Reach out to our Bard PowerPort Injury Lawyers today for more information.

We’re here to help you.