TAUT INTRADUCERS 10/BX7.5 FR X 3.5
Received Dec 18, 2018 · Event occurred Sep 19, 2018
Report 3003898360-2018-01042 · MDR key 8173974
Device
Product problems
- Break
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE SMALL SILICONE WASHER FELL OUT OF THE TAUT INTRODUCER PERITONEAL CATHETER INTO THE PATIENT'S ABDOMEN. THE SURGEON WAS ABLE TO RETRIEVE THE WASHER.
Additional Manufacturer Narrative
QN#(B)(4). PER DHR THE PRODUCT TAUT INTRADUCERS 10/BX7.5 FR X 3.5 LOT # 73E1700181 WAS MANUFACTURED ON 05/15/2017 A TOTAL OF 800 PIECES. LOT WAS RELEASED ON 05/19/2017. DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. CORRECTIVE ACTIONS CANNOT BE ESTABLISHED SINCE IT IS NECESSARY TO RECEIVE THE PHYSICAL SAMPLE TO PERFORM A PROPER INVESTIGATION AND CONFIRM THE ALLEGED DEFECT. AT THIS TIME DUE THE SAMPLE IS NOT AVAILABLE IS NOT POSSIBLE TO DETERMINE THE SOURCE OF THE DEFECT REPORTED. CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE THE PRODUCT SAMPLE IS NOT AVAILABLE TO PERFORM A PROPER INVESTIGATION AND DETERMINATE THE ROOT CAUSE.
Additional Manufacturer Narrative
QN# (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.
Description of Event or Problem
IT WAS REPORTED THAT THE SMALL SILICONE WASHER FELL OUT OF THE TAUT INTRODUCER PERITONEAL CATHETER INTO THE PATIENT'S ABDOMEN. THE SURGEON WAS ABLE TO RETRIEVE THE WASHER.