NEO MAPCATH STYLET 0.8FR
Received Feb 7, 2013 · Event occurred Jul 20, 2012
Report 3009124963-2013-00003 · MDR key 2971147
Device
Product problems
- Break
- Malposition of Device
Patient
6 MO
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A 0.8 FR NEO MAPCATH STYLET WAS PLACED IN A BARD 2FR PICC LINE. THE PICC WAS PLACED IN A BARD 2FR PICC LINE. THE PICC WAS PLACE IN THE PT HOWEVER THERE WERE ISSUES WITH MALPOSITION TO THE JUGULAR VEIN. ATTEMPTED PROPER POSITION. THE STYLET WAS REMOVED AND NOTED TO HAVE BROKEN OFF IN THE PT. RETRIEVED 4 DAYS LATER. NO INJURY TO PT.
Additional Manufacturer Narrative
THERE WAS NO REPORT OF INJURY. THE ACTUAL SAMPLE HAS NOT BEEN RETURNED FOR EVAL. SAMPLES FROM THE SAME LOT WERE TESTED AT GREATER THAN 17N WHICH IS GREATER THAN ANY FORCE EXPECTED IN THE CLINICAL SETTING. W/O A SAMPLE A DEFINITIVE CONCLUSION CAN NOT BE DRAWN.