BD recommended the removal of certain unused PowerPICC intravascular catheters from use or sale. In-use PowerPICC intravascular catheters also received updated instructions for use. Affected products include the 4 Fr. single lumen PowerPICC, SOLO and non-SOLO versions.
These devices offer short- or long-term peripheral access to the central venous system for intravenous therapy. They also enable the power injection of contrast media and central venous pressure monitoring.
BD identified an increase in material fatigue leaks associated with the affected catheters. Mostly, this occurs as a transverse/circumferential crack in the catheter body. BD’s investigation suggests this results from an issue with the material resin use to manufacture the catheter tubing.
Risks include infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy. BD reports 10 serious injuries associated with the issue.
Customers should destroy all unused product, the company said. If it’s currently in use, the company doesn’t recommend explanting the device unless damage is suspected. To reduce the likelihood of material fatigue leak for in-use catheters, BD recommends the use of adhesive-backed securement systems instead of compression-style securement systems. Customers should also use an appropriately sized securement system to accommodate the increase in diameter of the catheter in the taper region.
