STATLOCK SLIDING POST CRESCENT
Received Feb 26, 2021 · Event occurred Jan 28, 2021
Report 3006260740-2021-00524 · MDR key 11389219
Device
Generic name
Stand, Infusion
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Catalog number
PIC0220
Lot number
JUEV1827
Product problems
- Detachment of Device or Device Component
Narrative
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF JUEV1827 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem
IT WAS REPORTED WHEN DOING A DRESSING CHANGE AND REMOVING THE STATLOCK, THE PLASTIC WINGS DETACHED FROM THE STATLOCK ADHESIVE ALMOST PULLING THE PICC OUT OF THE PATIENT. ADDITIONAL INFORMATION RECEIVED 02/01/2021: DOES THE PATIENT HAVE AN INFECTIOUS DISEASE? UNKNOWN, MY DEPARTMENT DID NOT TAKE NOTE OF THE PARTICULAR PATIENTS THIS IS HAPPENING TO. WE ASSUME IT IS THE PRODUCT. I WILL SAY THAT A CONTRIBUTING FACTOR, IN HINDSIGHT, MAY BE USING SENSICARE ADHESIVE RELEASE SPRAY TO REMOVE DRESSINGS. PERHAPS IT IS REMOVING THE ADHESIVE UNDER THE PLASTIC WINGS.