MalfunctionNIF
14.5FX28CM HEMO-FLOW
Received Jun 9, 2011 · Event occurred May 1, 2011
Report 2518902-2011-00061 · MDR key 2185532
Device
Product problems
- Hole In Material
Patient
UNK
- No Information
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION HAS BEEN INITIATED. ADDITIONAL INFORMATION REGARDING THE EVENT AND DEVICE HAS BEEN REQUESTED. TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED. WHEN THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT 'WHEN CATHETER WAS REMOVED THERE WAS A HOLE AT THE TOP END OF THE LINE BELOW THE CUFF."