MalfunctionGBW
TAUT INTRADUCERS 10/BX7.5 FR X 3.5
Received Jun 22, 2017 · Event occurred May 15, 2017
Report 3003898360-2017-00737 · MDR key 6660485
Device
Product problems
- Break
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). 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 WHILE IN USE. THERE WAS NO PATIENT INJURY.
Additional Manufacturer Narrative
(B)(4). PER DHR THE PRODUCT TAUT INTRADUCERS 10/BX7.5 FR X 3.5, LOT # 73H1600183 WAS MANUFACTURED ON 08/15/2016 A TOTAL OF 800 PIECES. LOT WAS RELEASED ON 08/16/2016. DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT.
Description of Event or Problem
A PIECE OF THE DEVICE FELL OFF WHILE IN USE. THERE WAS NO PATIENT INJURY.