STATLOCK SLIDING POST TRICOT CRESCENT PAD INCLUDES SKIN PREP
Received May 13, 2021 · Event occurred Apr 22, 2021
Report 3006260740-2021-01829 · MDR key 11819999
Device
Generic name
Stand, Infusion
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Catalog number
PIC0220CE
Lot number
JUEV0697
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF JUEV0697 SHOWED TWO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER HAVE BEEN REPORTED FROM THE SAME FACILITY IN (B)(6).
Description of Event or Problem
IT WAS REPORTED BY FACILITY STAFF "OUR DIALYSIS CENTRE INFORMS US THAT DURING A DRESSING CHANGE OF THE DIALYSIS CATHETER IT WAS NOTICED THAT THE STATLOCK PICC PLUS WAS NO LONGER INTACT. AS THE STATLOCK IS APPLIED AS AN ADDITIONAL SAFETY MEASURE TO KEEP THE DIALYSIS CATHETER IN PLACE, THIS SAFETY MEASURE WAS NOT APPLICABLE HERE. WHEN THE DRESSING WAS REMOVED, THE PLASTIC HOLDER WAS NO LONGER ATTACHED TO THE ADHESIVE PATCH THAT ADHERES TO THE PATIENT'S SKIN. AFTER CARE OF THE DIALYSIS CATHETER, A NEW STATLOCK WAS APPLIED, BUT EVEN WITH THIS (AND THE 3RD ATTEMPT) IT WAS FOUND THAT THE PLASTIC HOLDER DETACHES VERY EASILY FROM THE ADHESIVE PATCH TO WHICH IT IS ATTACHED." THIS REPORT ADDRESSES THE SECOND OF THREE DEVICES.