MalfunctionOVN
DEK BL MF 0 FX45 2N 48" BARD
Received Sep 1, 2015 · Event occurred Jul 29, 2015
Report 3004365956-2015-00263 · MDR key 5046027
Device
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). THE DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. THE DEVICE SAMPLE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.
Description of Event or Problem
ALLEGED EVENT: THE BULLET WAS NOT CAUGHT BY THE DEVICE AND THE SUTURE BROKE. THE BULLET REMAINED IN THE PATIENT AND WAS UNABLE TO BE REMOVED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.