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Early Alert: Intravascular PICC Catheter Issue from BD
The FDA is aware that BD and their subsidiary Bard Access Systems have issued a letter to affected customers recommending certain unused PowerPICC Intravascular Catheters be removed from where they are used or sold and in-use PowerPICC Intravascular Catheters have updated instructions for use.
BD has identified an increase in material fatigue leaks associated with the affected catheters mostly seen as a transverse/circumferential crack in the catheter body. BD’s investigations suggest this results from an issue with the material resin use to manufacture the catheter tubing. The risks associated with material fatigue leakage include infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy. BD has reported 10 serious injuries associated with this issue.
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact BD via the North American Regional Complaint Center at productcomplaints@bd.com or 844-823-5433.
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