TAUT INTRADUCERS 10/BX7.5 FR X 3.5

Additional Manufacturer Narrative

(B)(4). THE CUSTOMER RETURNED ONE UNIT PI-93 TAUT INTRADUCERS 10/BX 7.5 FR X 3.5 FOR INVESTIGATION. THE ONLY PART OF THE DEVICE THAT WAS NOT RETURNED WAS THE PROTECTOR SLEEVE. THE CLEAR DISC THAT'S SUPPOSED TO BE INSIDE OF THE CHECK VALVE WAS RETURNED LOOSE. THE DISC MOST LIKELY FELL OUT OF THE CHECK VALVE DUE TO THE CATHETER GETTING STUCK ON IT AND PULLING IT OUT. IT COULD NOT BE DETERMINED WHY THE CATHETER GOT STUCK ON THE CLEAR DISC. THE CATHETER THAT WAS USED WAS NOT RETURNED. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED. 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." OTHER REMARKS: THE REPORTED COMPLAINT OF "DIFFICULTY INSERTING CATH IN INTRODUCER" WAS CONFIRMED BASED UPON THE SAMPLE RECEIVED. THE CLEAR DISC FROM THE CHECK VALVE WAS RETURNED LOOSE. NO OTHER PROBLEMS WERE FOUND WITH THE DEVICE. IT APPEARS THAT THE CLEAR DISC MOST LIKELY FELL OUT OF THE CHECK VALVE DUE TO THE CATHETER GETTING STUCK ON THE DISC AND PULLING IT OUT. HOWEVER, IT COULD NOT BE DETERMINED WHY THE CATHETER WOULD GET STUCK ON THE DISC. 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

UPON USE OF INTRADUCER, DURING INSERTION OF THE CATHETER, THE VERY SMALL, CLEAR DISC ON TOP OF INTRADUCER OR SEAL FELL INTO THE PATIENT. THE CUSTOMER STATED THAT THEY MAY BE HITTING THE DISC WITH THE EDGE OF THE CATHETER AND PUSHING IT THROUGH BUT THAT IT HAS HAPPENED ON THREE SEPARATE OCCASIONS WITH THREE DIFFERENT LOT NUMBERS. NO PATIENT INJURY OR NEED TO RETURN FOR TREATMENT, THE PHYSICIAN IS SIMPLY REMOVING THE PIECE THEN AND THERE.

Additional Manufacturer Narrative

(B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT TAUT INTRODUCERS 10/BX7.5 FR X 3.5, LOT #73K1600792 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

UPON USE OF INTRODUCER, DURING INSERTION OF THE CATHETER, THE VERY SMALL, CLEAR DISC ON TOP OF INTRODUCER OR SEAL FELL INTO THE PATIENT. THE CUSTOMER STATED THAT THEY MAY BE HITTING THE DISC WITH THE EDGE OF THE CATHETER AND PUSHING IT THROUGH BUT THAT IT HAS HAPPENED ON THREE SEPARATE OCCASIONS WITH THREE DIFFERENT LOT NUMBERS. NO PATIENT INJURY OR NEED TO RETURN FOR TREATMENT, THE PHYSICIAN IS SIMPLY REMOVING THE PIECE THEN AND THERE.