MalfunctionFOX
STATLOCK CV PLUS SLIDING POST, 25 BOX
Received Jan 29, 2021 · Event occurred Jan 8, 2021
Report 3006260740-2021-00143 · MDR key 11252081
Device
Generic name
Stand, Infusion
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Catalog number
CV0226CE
Lot number
JUEV0551
Product problems
- Difficult to Open or Close
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF JUEV0551 SHOWED FOURTEEN 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).
Description of Event or Problem
IT WAS REPORTED THAT THE LOCKING CLAMS ON THE STATLOCK ARE EXTREMELY HARD TO CLOSE, SOMETIMES IMPOSSIBLE. IT WAS REPORTED THIS EVENT OCCURRED FIFTEEN TIMES. THIS REPORT ADDRESSES THE FOURTH EVENT.