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.
** 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.
The material resin issue highlights the critical role of supply chain management in medical device manufacturing. How can manufacturers ensure consistent quality and rigorous testing of raw materials to prevent similar incidents?
That’s a great point! Supply chain management is paramount. Beyond rigorous testing, I think fostering transparent relationships with suppliers and implementing robust traceability systems are crucial for ensuring consistent quality. Perhaps regular audits and collaborative problem-solving could also prevent similar issues from arising.
Editor: MedTechNews.Uk
Thank you to our Sponsor Esdebe
Material fatigue leading to leaks – talk about a bad day! Besides better resin, are we also rethinking the catheter’s design? Perhaps a less stressful geometry could help these PICCs go the distance?
That’s a fantastic point! Rethinking the catheter design and exploring less stressful geometries could definitely contribute to improved durability. It’s crucial that design considerations work in conjunction with material advancements for optimal performance. It would be interesting to study how different geometries cope with material stress! Thanks for raising that important aspect.
Editor: MedTechNews.Uk
Thank you to our Sponsor Esdebe
Material fatigue, 10 serious injuries… that resin must have been having a *really* bad day. Anyone know if they’ve considered therapy for the resin? Perhaps a good venting session (pun intended!) could have prevented all this!
That’s a funny take! It does highlight the human element we sometimes forget in manufacturing. While I don’t know if resin therapy is on the table, the manufacturer is looking into more resilient materials. Maybe a stress test that involves tiny weights and mini treadmills is the answer?
Editor: MedTechNews.Uk
Thank you to our Sponsor Esdebe