TAUT INTRADUCERS 10/BX7.5 FR X 3.5
Received Jul 23, 2018 · Event occurred Jun 8, 2018
Report 3003898360-2018-00579 · MDR key 7710429
Device
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence 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 #73K1700687 INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. 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 PER MW5077802 THAT WITH INITIAL USE OF THE TAUT INTRADUCER PERITONEAL CATHETER THE SMALL RUBBER SEAL DETACHED FROM THE DEVICE AND WAS RETRIEVED FROM WITHIN THE PATIENT'S ABDOMEN.
Description of Event or Problem
IT WAS REPORTED PER MW5077802 THAT WITH INITIAL USE OF THE TAUT INTRADUCER PERITONEAL CATHETER THE SMALL RUBBER SEAL DETACHED FROM THE DEVICE AND WAS RETRIEVED FROM WITHIN THE PATIENT'S ABDOMEN.
Additional Manufacturer Narrative
QN#(B)(4). THE REPORTED COMPLAINT OF "IMPROPER CLIP CLOSURE" WAS NOT CONFIRMED BASED UPON THE SAMPLE RECEIVED. THE CUSTOMER RETURNED 2 LOOSE CLIPS THAT WERE PROPERLY CLOSED WITH NO DEFECTS OBSERVED. SINCE NO CLIPS WERE RETURNED OTHER THAN THE TWO CLOSED ONES, A FUNCTIONAL INSPECTION WAS NOT PERFORMED. NO FUNCTIONAL ISSUES WERE FOUND WITH THE RETURNED SAMPLES AND THE APPLIER WAS NOT RETURNED. THEREFORE, THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE SAMPLE HAS BEEN SENT TO THE SUPPLIER OF THE PRODUCT AND A NONCONFORMANCE HAS BEEN OPENED TO FURTHER INVESTIGATE THIS COMPLAINT ISSUE. REFERENCE FILES (B)(4) FOR INVESTIGATION PHOTOS. 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. THE CLEAR DISC IN THE CHECK VALVE WAS MISSING FROM THE CHECK VALVE. THE SAMPLE HAS BEEN SENT TO THE SUPPLIER OF THE PRODUCT AND NONCONFORMANCE HAS BEEN OPENED TO FURTHER INVESTIGATE THIS COMPLAINT ISSUE. THE REPORTED COMPLAINT OF "SEAL DETACHED" WAS CONFIRMED BASED UPON THE SAMPLE RECEIVED. THE CLEAR DISC FROM THE CHECK VALVE WAS MISSING FROM THE DEVICE AND WAS NOT RETURNED. THE DISC COULD HAVE FALLEN OUT OF THE CHECK VALVE DUE TO THE CATHETER GETTING STUCK ON IT AND PULLING IT OUT. HOWEVER , IT COULD NOT BE CONFIRMED WHETHER OR NOT THIS WAS THE CASE. THE CATHETER THAT WAS USED WAS NOT RETURNED. IT CANNOT BE DETERMINED WHAT CAUSED THE REPORTED COMPLAINT ISSUE. HOWEVER, THE SAMPLE HAS BEEN SENT TO THE SUPPLIER OF THE PRODUCT AND A NONCONFORMANCE HAS BEEN OPENED TO FURTHER INVESTIGATE THIS COMPLAINT ISSUE.