MalfunctionNIF
14.5 FX 28 CM HEMO-FLOW
Received Jan 5, 2012 · Event occurred Jul 22, 2011
Report 2518902-2012-00002 · MDR key 2427223
Device
Product problems
- Fluid/Blood Leak
Patient
UNK
- No Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS "BLOOD LEAKAGE FROM HUB AND LUMEN JUNCTION OF THE CATHETER (MAIN TUBING OF LUMENS).
Additional Manufacturer Narrative
AN INVESTIGATION HAS BEEN INITIATED. A REVIEW OF THE MFG RECORDS INDICATED THAT ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS WERE SATISFIED. WHEN THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.