MalfunctionFOX
STATLOCK PICC PLUS CRESCENT TRICOT FIX-POST
Received Mar 26, 2021 · Event occurred Mar 4, 2021
Report 3006260740-2021-01017 · MDR key 11577179
Device
Generic name
Stand, Infusion
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Catalog number
PIC0222
Lot number
UNKNOWN
Product problems
- Patient-Device Incompatibility
- Patient-Device Incompatibility
Patient
Not reported
- Erythema
- Erythema
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 THAT THE STATLOCK WAS DIFFICULT TO REMOVE SINCE THE ADHESIVE ADHERED TOO WELL. IT WAS REMOVED PER MANUFACTURER'S RECOMMENDATIONS AND IT RESULTED IN REDNESS ON THE PATIENT'S SKIN. NO OTHER INFORMATION WAS PROVIDED.