Dive Brief:
- BD is recommending customers destroy certain unused intravascular catheters tied to reports of 10 serious injuries, the Food and Drug Administration said Friday in an early alert. The company did not recommend explanting catheters already in use by patients, unless damage is suspected.
- In a March 11 recall letter, BD identified an increase in cracks due to “material fatigue” in the 4 Fr Single Lumen PowerPICC catheters that can cause the devices to leak.
- The risks to patients include leaking of IV fluids into surrounding tissue, bleeding, embolism, infection and interruption of therapy.
Dive Insight:
BD’s PowerPICC catheters provide access to major veins for intravenous therapy, power injection of contrast media, and blood pressure monitoring.
A company investigation suggested the material fatigue cracks in the catheter body are due to an issue with the resin used to manufacture the catheter tubing, the FDA said. To reduce the risk of leaks, BD recommended switching to adhesive-based systems to secure the catheters, making sure the securement system is appropriately sized and fully inserting the catheter.
The early alert is part of an FDA pilot program, launched in November, intended to inform the public sooner about potential high-risk device problems.
BD’s recall of intravascular catheters is the second from the company to be flagged in an early alert. In February, the FDA published an early alert for BD’s Rotarex device used to break up clots in blood vessels. The device was linked to 30 serious injuries and four deaths. The agency said part of the device could break and injure vessels, with the potential for severe bleeding.
Other early alerts have been issued for devices including Olympus reusable endoscope accessories, Calyxo CVAC aspiration systems and Medline fluid delivery sets.
