MalfunctionGBW
TAUT INTRADUCERS 10/BX7.5 FR X 3.5
Received Apr 27, 2017 · Event occurred Mar 22, 2017
Report 3003898360-2017-00438 · MDR key 6525823
Device
Product problems
- Material Separation
- Material Separation
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT TAUT INTRADUCERS 10/BX7.5 FR X 3.5, LOT #73H1600183 INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.
Description of Event or Problem
A PIECE OF THE DEVICE FELL OFF DURING USE. THE PATIENT CONDITION WAS REPORTED AS FINE.