MalfunctionFOX
STATLOCK SLIDING POST TRICOT CRESCENT PAD W/ SKIN PREP
Received May 21, 2021 · Event occurred Apr 26, 2021
Report 3006260740-2021-01927 · MDR key 11864095
Device
Generic name
Stand, Infusion
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Model number
N/ACatalog number
PIC0220CE
Lot number
JUEV0541
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 JUEV0541 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem
IT WAS REPORTED SEVERAL INSTANCES OF THE PLASTIC RETAINING CLIP PEELING AWAY FROM THE DRESSING PORTION OF THIS PARTICULAR BATCH OF STATLOCKS WHILE IN USE. IT WAS STATED THAT THE FACILITY OPENED ONE FROM STOCK AND THE GLUE SEEMED UNUSUALLY WEAK. IT IS UNKNOWN THE NUMBER OF DEVICES USED.