MalfunctionFPK
MEDEX SMALL BORE EXTENSION SET
Received Nov 19, 2014
Report 2183502-2014-00880 · MDR key 4286429
Device
Generic name
Fpk - Tubing, Fluid Delivery
Manufacturer
Smiths Medical, Inc.Model number
NACatalog number
MX43661
Lot number
2770170
Product problems
- Disassembly
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
USER FACILITY REPORTED THAT THE LISTED DEVICE BECAME DISASSEMBLED DURING USE. THERE WERE NO ADVERSE EFFECTS TO PATIENT REPORTED.
Additional Manufacturer Narrative
THE DEVICE IS CURRENTLY BEING EVALUATED; THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED.