STATLOCK CV PLUS SLIDING POST, TRICO HYDROCOLLOID CRESCENT PAD, 25 BOX
Received Apr 9, 2021 · Event occurred Mar 18, 2021
Report 3006260740-2021-01256 · MDR key 11644233
Device
Generic name
Stand, Infusion
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Catalog number
CV0226
Lot number
JUDY2115
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 JUDY2115 SHOWED THREE 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). DEVICE NOT RETURNED FOR EVALUATION.
Description of Event or Problem
IT WAS REPORTED THAT THE PLASTIC PIECE OF THE STATLOCK DEVICE IS DETACHING FROM THE ADHESIVE BACKING. IT WAS FURTHER REPORTED THAT THIS INCIDENT HAS OCCURRED THREE TIMES OVER THE LAST TWO WEEKS. THIS REPORT ADDRESSES THE THIRD OCCURRENCE.