TAUT INTRADUCERS 10/BX7.5 FR X 3.5

Additional Manufacturer Narrative

QN#(B)(4). MEDWATCH REPORT # (B)(4) PER DHR THE PRODUCT TAUT INTRODUCERS 10/BX7.5 FR X 3.5 LOT # 73D1700302 WAS MANUFACTURED ON 04/24/2017 A TOTAL OF (B)(4) PIECES. LOT WAS RELEASED ON 04/27/2017. 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. IF THE ALLEGED DEFECT SAMPLES BECOME AVAILABLE AT A LATER DATE, THIS COMPLAINT WILL BE UPDATED ACCORDINGLY.

Description of Event or Problem

IT WAS REPORTED THAT AS THE DEVICE WAS BEING USED THE SMALL SILICONE WASHER SEPARATED FROM THE TAUT INTRODUCER PERITONEAL CATHETER AND FELL ONTO THE STERILE FIELD FOLLOWING THE USE OF THE CHOLANGIOGRAM CATHETER. THE WASHER WAS REMOVED INTACT FROM THE STERILE FIELD.

Additional Manufacturer Narrative

QN#(B)(4). MEDWATCH REPORT #5080440 THE CUSTOMER RETURNED ONE UNIT PI-93 TAUT INTRADUCERS 10/BX 7.5 FR X 3.5 FOR INVESTIGATION. THE RETURNED SAMPLE WAS VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED SAMPLE REVEALED THAT ONLY THE CHECK VALVE AND INTRADUCER CATHETER/CATHETER HUB WERE RETURNED. THE NEEDLE HUB/INTRADUCER STYLET AND PROTECTOR WERE NOT RETURNED. IT WAS OBSERVED THAT THE CLEAR DISC IS MISSING FROM THE CHECK VALVE. THE CLEAR DISC 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. THE SAMPLE HAS BEEN SENT TO THE SUPPLIER OF THE PRODUCT AND A NON-CONFORMANCE HAS BEEN OPENED TO FURTHER INVESTIGATE THIS COMPLAINT ISSUE. THE SAMPLE HAS BEEN SENT TO THE SUPPLIER OF THE PRODUCT AND A NON-CONFORMANCE HAS BEEN OPENED TO FURTHER INVESTIGATE THIS COMPLAINT ISSUE. 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." 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 NON-CONFORMANCE HAS BEEN OPENED TO FURTHER INVESTIGATE THIS COMPLAINT ISSUE.

Description of Event or Problem

IT WAS REPORTED THAT AS THE DEVICE WAS BEING USED THE SMALL SILICONE WASHER SEPARATED FROM THE TAUT INTRODUCR PERITONEAL CATHETER AND FELL ONTO THE STERILE FIELD FOLLOWING THE USE OF THE CHOLANGIOGRAM CATHETER. THE WASHER WAS REMOVED INTACT FROM THE STERILE FIELD.

Additional Manufacturer Narrative

(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 AS THE DEVICE WAS BEING USED THE SMALL SILICONE WASHER SEPARATED FROM THE TAUT INTRODUCER PERITONEAL CATHETER AND FELL ONTO THE STERILE FIELD FOLLOWING THE USE OF THE CHOLANGIOGRAM CATHETER. THE WASHER WAS REMOVED INTACT FROM THE STERILE FIELD.