The FDA has issued a safety warning regarding a potentially high-risk issue involving certain BD PowerPICC Intravascular Catheters.
The affected devices are 4 Fr. Single Lumen PowerPICC catheters, both SOLO and non-SOLO versions, manufactured by BD and its subsidiary Bard Access Systems, according to an April 18 FDA news release.
The warning follows reports of material fatigue leaks in the catheters attributed to a resin issue in the tubing. This has led to cracking in the catheter body with risk of leakage, infection, bleeding, embolism and therapy distribution.
BD issued a recall notice to healthcare providers March 11, advising them to destroy unused affected catheters and review the updated usage instructions for those already in use.
For catheters in use, BD advises clinicians to monitor for signs of damage such as infusion pain, swelling, or leakage at the insertion site.
Ten serious injuries have been reported as a result of the recall, the release said.
