NEO MAPCATH STYLET 0.8FR
Received Feb 1, 2013 · Event occurred Jan 4, 2013
Report 3009124963-2013-00001 · MDR key 2957239
Device
Product problems
- Detachment Of Device Component
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
EVENT DESC: DURING AN OVER THE CATH EXCHANGE USING THE NAVIGATOR INSTRUMENT THE NURSE WAS HAVING DIFFICULTY PLACING THE LINE. THE NP HAD REMOVED THE WIRE AND THE LINE BECAUSE SHE COULDN'T GET IT POSITIONED APPROPRIATELY. UPON REMOVAL SHE NOTICED A PIECE OF THE SENSOR WIRE WAS IN THE END OF THE CATHETER (APPROXIMATELY 10CM). IT ALL CAME OUT WITH THE LINE.
Additional Manufacturer Narrative
THERE WAS NO REPORT OF INJURY. THE ACTUAL SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION. SAMPLES FROM THE SAME LOT WERE TESTED AT GREATER THAN 17N WHICH IS GREATER THAN ANY FORCE EXPECTED IN THE CLINICAL SETTING. WITHOUT A SAMPLE A DEFINITIVE CONCLUSION CAN NOT BE DRAWN.