MalfunctionFOX
STATLOCK
Received Jan 27, 2021 · Event occurred Jan 4, 2021
Report 3006260740-2021-00063 · MDR key 11237372
Device
Generic name
Stand, Infusion
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Model number
N/ACatalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
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) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.
Description of Event or Problem
IT WAS REPORTED "HOME CARE NURSE HEARD FROM PATIENT THAT THEY HAD A REACTION TO THE ADHESIVE IN STATLOCK. AT THE TIME SHE HAD SPOKEN WITH THEM, THEY HAD THE PICC FOR ABOUT 2 MONTHS AND HAD A DIFFERENT CATHETER SECUREMENT (WING GUARD WAS MENTIONED)."