STATLOCK PICC PLUS SLIDING POST, CRESCENT PAD, INCLUDES SKIN PREP
Received Nov 1, 2022 · Event occurred Oct 13, 2022
Report 3006260740-2022-04239 · MDR key 15712194
Device
Generic name
Stand, Infusion
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Model number
N/ACatalog number
VPPCSPCE
Lot number
JUFZ1882
Product problems
- Difficult to Remove
- Difficult to Remove
Patient
Unknown
- Erythema
- Blister
- Erythema
- Blister
Narrative
Additional Manufacturer Narrative
THE DATE OF EVENT WAS NOT PROVIDED BY THE COMPLAINANT/REPORTER, THE DATE REFLECTED IN THIS REPORT IS THE DATE BD BECAME AWARE OF THE EVENT. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF JUFZ1882 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem
IT WAS REPORTED INCIDENT DETAILS: PATIENT HAS REPORTED REACTING TO THE STATLOCK. SKIN UNDER THE STATLOCK IS RED AND WITH SMALL BLISTER. PICC LINE HAS SECURECATH IN PLACE, THE STATLOCK HAS BEEN REMOVED. THEY HAVE APPLIED 2 MEPITEL DRESSINGS TO THE PICC LINE TO MAKE THE LINE MORE SECURE