MalfunctionFKA
HEMOSPLIT CATHETER
Received Jan 19, 2012
Report 3006260740-2012-00021 · MDR key 2439949
Device
Product problems
- Break
- Detachment Of Device Component
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE HEMOSPLIT CATHETER RIPPED AT THE LEVEL OF THE ROBUST EXTENSION LEGS.
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THIS TIME FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.