MalfunctionFOX
STATLOCK SLIDING POST TRICOT CRESCENT PAD INCLUDES SKIN PREP
Received Aug 4, 2021 · Event occurred Jul 14, 2021
Report 3006260740-2021-03111 · MDR key 12275423
Device
Generic name
Stand, Infusion
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Model number
N/ACatalog number
PIC0220CE
Lot number
JUEU2084
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 JUEU2084 SHOWED TWO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (JUEU2084) HAVE BEEN REPORTED FROM THE SAME FACILITY IN (B)(4).
Description of Event or Problem
IT WAS REPORTED THE "CLICK" PART EASILY DETACHED FROM THE PATCH ON THREE DEVICES. IT WAS STATED THIS OCCURRED PRIOR TO USE ON PATIENTS. THIS REPORT ADDRESSES THE SECOND DEVICE.