BD Catheter Alert

Summary

The FDA issued an early alert for BD PowerPICC catheters due to a risk of material fatigue leaks, potentially causing serious injuries. BD recommends discarding unused affected catheters and provides updated instructions for those in use. Healthcare providers should monitor patients for signs of catheter fracture and consider alternative infusion methods.

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** Main Story**

BD Catheter Leak Prompts FDA Early Alert

The Food and Drug Administration (FDA) recently issued an early alert concerning specific BD PowerPICC intravascular catheters due to an increased risk of material fatigue leaks. This alert follows reports of 10 serious injuries linked to these catheters. The FDA, through its pilot program designed to provide rapid public warnings about potentially high-risk medical devices, is working to keep healthcare providers and the public informed. BD, in conjunction with its subsidiary, Bard Access Systems, initiated a recall on March 11, 2025, urging healthcare providers to take immediate action.

Understanding the Issue: Material Fatigue and Potential Risks

The affected catheters are the 4 Fr Single Lumen PowerPICC, including both SOLO and non-SOLO versions. BD’s investigation suggests the leaks stem from a problem with the material resin used in manufacturing the catheter tubing, leading to transverse or circumferential cracks in the catheter body. These cracks can cause the catheter to leak, potentially leading to serious complications.

These complications include infiltration and extravasation, which involve the leakage of intravenous fluids into surrounding tissues. Other risks include discomfort, phlebitis (inflammation of the vein), bleeding, air embolism (air bubbles in the bloodstream), foreign body embolism (obstruction of a blood vessel by a foreign object), infection, and interruption of therapy.

Recommendations for Healthcare Providers and Patients

BD advises healthcare providers to immediately remove and dispose of any unused affected catheters. For catheters currently in use, BD does not recommend removal unless there is suspicion of damage. Instead, healthcare providers should weigh the patient’s individual infusion needs, the availability of alternative access options, and the overall risks and benefits of continued catheter use.

Minimizing Risks: Best Practices for In-Use Catheters

BD recommends several precautions to reduce the risk of leaks in catheters currently in use:

• Securement Systems: Use adhesive-backed securement systems (such as StatLock, GripLock, Tegaderm, or steri-strips) instead of compression-style systems. Also ensure the securement system is appropriately sized to accommodate the catheter’s tapered region.
• Catheter Insertion: Fully insert the PICC as close as possible to the zero-centimeter mark. This positioning utilizes the kink-resistant, tapered region of the catheter and is associated with lower leakage rates.
• Monitoring: Patients and healthcare providers should closely monitor for any signs or symptoms of catheter fracture. These include pain during infusion, swelling in the arm not related to deep vein thrombosis (DVT), difficulty withdrawing blood, and leakage of infusate around the insertion site.

Immediate Actions for Suspected Catheter Damage

If catheter damage is suspected, take the following steps:

• Stop Infusion: Immediately discontinue any infusion.
• Check for Damage: Follow your institution’s guidelines and check for damage, including catheter fracture.
• Remove Damaged Catheter: If a fracture is confirmed, remove the catheter and establish an alternative route for intravascular access.

The Bigger Picture: Medical Device Safety and Innovation

This recall underscores the ongoing need for rigorous testing and monitoring of medical devices. While advancements in medical technology offer numerous benefits, potential risks must always be carefully considered and addressed. The FDA’s early alert program, while still in its pilot phase, represents a vital step towards enhancing patient safety by providing timely information about potentially hazardous devices. This proactive approach empowers healthcare providers to make informed decisions and take appropriate action to protect their patients. The incident also emphasizes the importance of continuous improvement in material science and manufacturing processes to minimize the risk of device failure.