TAUT INTRADUCERS 10/BX7.5 FR X 3.5
Received Jun 6, 2018 · Event occurred May 10, 2018
Report 3003898360-2018-00380 · MDR key 7575091
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 INVESTIGATION IS PENDING. THE DEVICE HISTORY REVIEW FOR THE PRODUCT TAUT INTRADUCERS 10/BX7.5 FR X 3.5 LOT #73J1700667 INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE FELL APART DURING THE PROCEDURE, THE BROWN PLASTIC PIECE CAME LOOSE. THERE WAS NO PATIENT INJURY,
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 CLEAR DISC AND THE ORANGE VALVE THAT ARE SUPPOSED TO BE INSIDE OF THE CHECK VALVE WERE RETURNED LOOSE. THE REST OF THE DEVICE WAS RETURNED ASSEMBLED INCORRECTLY. THE DEVICE WAS RETURNED WITH THE CHECK VALVE CONNECTED TO THE CATHETER HUB AND THE INTRODUCER STYLET INSERTED INTO BOTH. HOWEVER, THE STYLET SHOULD BE PLACED THROUGH THE CATHETER HUB WITH THE CHECK VALVE CONNECTED TO THE NEEDLE HUB OF THE STYLET. IT COULD NOT BE CONFIRMED IF THE END USER USED THE DEVICE EXACTLY HOW IT WAS RETURNED, BUT IF IT WAS, THE STYLET COULD HAVE CAUGHT THE DISC AND VALVE AND PULLED THEM OUT OF THE DEVICE. ALSO, THE DISC AND VALVE COULD HAVE FALLEN OUT OF THE DEVICE DUE TO THE CATHETER GETTING STUCK ON IT AND PULLING IT OUT. IT COULD NOT BE DETERMINED WHY THE CATHETER OR STYLET GOT STUCK ON THE CLEAR DISC AND ORANGE VALVE. THE CATHETER THAT WAS USED WAS NOT RETURNED. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED. REFERENCE FILES (B)(4) FOR INVESTIGATION PH OTOS. 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, OTHER REMARKS: 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 "FELL APART DURING USE" WAS CONFIRMED BASED UPON THE SAMPLE RECEIVED. THE CLEAR DISC AND ORANGE VALVE FROM THE CHECK VALVE WERE RETURNED LOOSE. THE REST OF THE DEVICE WAS RETURNED ASSEMBLED INCORRECTLY. THE DEVICE WAS RETURNED WITH THE CHECK VALVE CONNECTED TO THE CATHETER HUB AND THE INTRADUCER STYLET INSERTED INTO BOTH. HOWEVER, THE STYLET SHOULD BE PLACED THROUGH THE CATHETER HUB WITH THE CHECK VALVE CONNECTED TO THE NEEDLE HUB OF THE STYLET. IT COULD NOT BE CONFIRMED IF THE END USER USED THE DEVICE EXACTLY HOW IT WAS RETURNED, BUT IF IT WAS, THE STYLET COULD HAVE CAUGHT THE DISC AND VALVE AND PULLED THEM OUT OF THE DEVICE. ALSO, THE DISC AND VALVE COULD HAVE FALLEN OUT OF THE DEVICE DUE TO THE CATHETER GETTING STUCK ON IT AND PULLING IT OUT. IT COULD NOT BE DETERMINED WHY THE CATHETER OR STYLET GOT STUCK ON THE CLEAR DISC AND ORANGE VALVE. THE CATHETER THAT WAS USED 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
IT WAS REPORTED THAT THE DEVICE FELL APART DURING THE PROCEDURE, THE BROWN PLASTIC PIECE CAME LOOSE. THERE WAS NO PATIENT INJURY,