The FDA has reported on a letter from BD and their subsidiary Bard Access Systems “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 is recommending that healthcare providers with the affected products “destroy all unused product.” If the product is currently in use with a patient, “BD is not recommending the device be explanted unless damage is suspected…Patients and users should observe PICCs for any signs or symptoms that may be consistent with catheter fracture. These signs and symptoms include pain upon infusion, swelling of the arm not related to DVT, inability to withdraw blood, and leakage of infusate around the insertion site."
If catheter damage is suspected, “immediately stop any infusion,” and if a fracture is confirmed, “the catheter should be removed and an alternative route for intravascular access should be obtained.”
The early alert letter was sent out because “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…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.”
Matt MacKenzie | Associate Editor
Matt is Associate Editor for Healthcare Purchasing News.
