MalfunctionFOX
STATLOCK PICC PLUS SLIDING POST, CRESCENT PAD, INCLUDES SKIN PREP
Received Apr 15, 2021 · Event occurred Mar 3, 2021
Report 3006260740-2021-01343 · MDR key 11675537
Device
Generic name
Stand, Infusion
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Model number
N/ACatalog number
VPPCSPCE
Lot number
JUES2208
Product problems
- Misconnection
- Misconnection
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 JUES2208 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (JUES2208) HAVE BEEN REPORTED FROM THE SAME FACILITY IN (B)(6).
Description of Event or Problem
IT WAS REPORTED THAT THE CLAW OF THE RETAINER WAS FOUND TO BE BROKEN. IT WAS STATED THIS OCCURRED WITH TWO DEVICES. THERE WAS NO REPORTED PATIENT CONTACT. THIS REPORT ADDRESSES THE SECOND DEVICE.