MalfunctionFOX
STATLOCK
Received Jan 27, 2021 · Event occurred Jan 4, 2021
Report 3006260740-2021-00064 · MDR key 11237455
Device
Generic name
Stand, Infusion
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Model number
N/ACatalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Difficult to Remove
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 WAS DOING A DRESSING CHANGE AND FOUND STATLOCK VERY DIFFICULT TO REMOVE FROM THE SKIN."