MalfunctionFOX
STATLOCK PICC PLUS CRESCENT SLIDING POST
Received Oct 5, 2021 · Event occurred Sep 14, 2021
Report 3006260740-2021-04127 · MDR key 12576948
Device
Generic name
Stand, Infusion
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Model number
N/ACatalog number
PIC0220
Lot number
JUEU2113
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 JUEU2113 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem
IT WAS REPORTED THAT STATLOCK CONSISTS OF PLASTIC PIECE AND A THICK PLASTER. BOTH PARTS CAME LOOSE FROM EACH OTHER CAUSING THE CATHETER TO COME OUT OF THE PATIENT'S SKIN. THIS OCCURRED DURING USE.