TAUT INTRADUCERS 10/BX7.5 FR X 3.5
Received May 4, 2017 · Event occurred Apr 10, 2017
Report 3003898360-2017-00445 · MDR key 6543897
Device
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
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 INTRODUCERS 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
THE LUER LOCK TIP LOOSENED AND FELL INTO THE PATIENT'S ABDOMEN DURING THE PROCEDURE. THE TIP WAS RETRIEVED. THERE WAS NO PATIENT INJURY OR CONSEQUENCE.
Additional Manufacturer Narrative
(B)(4). THE CUSTOMER RETURNED ONE UNIT PI-93 TAUT INTRADUCERS 10/BX 7.5 FR X 3.5 FOR INVESTIGATION. ONLY THE CHECK VALVE WAS RETURNED. A PIECE OF THE CHECK VALVE FELL OUT AND WAS RETURNED LOOSE. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED. IT COULD NOT BE DETERMINED WHAT CAUSED THE PIECE TO FALL OUT OF THE CHECK VALVE SINCE THE REST OF THE DEVICE WAS NOT RETURNED. (B)(4). THE IFU FOR THIS PRODUCT, L03610, WAS REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. THE IFU STATES, "INSERT THE INTRADUCER ASSEMBLY THROUGH THE ABDOMINAL WALL USING A CONTINUOUS, CONTROLLED, SLOW, FORWARD MOTION. UNDER DIRECT VISUALIZATION USING THE LAPAROSCOPE, PENETRATE THE PERITONEUM UNTIL THE CATHETER TIP IS JUST VISIBLE WITHIN THE PERITONEAL CAVITY." "IMMEDIATELY UPON ENTRY INTO THE PERITONEAL CAVITY, HOLD THE INTRADUCER IN PLACE AND WITHDRAW THE NEEDLE COMPLETELY. REMOVE CHECK VALVE FROM NEEDLE HUB AND REINSTALL ON INTRADUCER CATHETER HUB." A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS IT CANNOT BE DETERMINED WHAT CAUSED THE COMPLAINT ISSUE. ONLY THE CHECK VALVE WAS RETURNED WITH A PIECE OF THE CHECK VALVE THAT FELL OUT. SINCE THE OTHER REMARKS: REST OF THE ACTUAL SAMPLE WAS NOT RETURNED; IT COULD NOT BE DETERMINED HOW THE PIECE OF THE CHECK VALVE FELL OUT OF THE DEVICE. THE REPORTED COMPLAINT OF "FELL APART DURING USE" WAS CONFIRMED BASED UPON THE SAMPLE RECEIVED. THE CUSTOMER ONLY RETURNED THE CHECK VALVE AND A PIECE OF THE CHECK VALVE THAT FELL OUT. THE REST OF THE DEVICE WAS NOT RETURNED. IT COULD NOT BE DETERMINED WHAT CAUSED THE PIECE TO FALL OUT OF THE CHECK VALVE SINCE THE REST OF THE DEVICE WAS NOT RETURNED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE DEVICE WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. IT CANNOT BE DETERMINED WHAT CAUSED THE REPORTED COMPLAINT ISSUE. NO FURTHER ACTION WILL BE TAKEN.
Description of Event or Problem
THE LUER LOCK TIP LOOSENED AND FELL INTO THE PATIENT'S ABDOMEN DURING THE PROCEDURE. THE TIP WAS RETRIEVED. THERE WAS NO PATIENT INJURY OR CONSEQUENCE.