TAUT INTRADUCERS 10/BX7.5 FR X 3.5

Additional Manufacturer Narrative

(B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT TAUT INTRADUCERS 10/BX7.5 FR X 3.5, LOT #73H1600885 INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. THE FACILITY HAS COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. 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. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED SINCE THE PRODUCT SAMPLE IS NOT AVAILABLE TO PERFORM A PROPER INVESTIGATION AND DETERMINE THE ROOT CAUSE. IF THE ALLEGED DEFECT SAMPLES BECOME AVAILABLE AT A LATER DATE, THIS COMPLAINT WILL BE UPDATED ACCORDINGLY. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS

Description of Event or Problem

TAUT INTRADUCER PERITONEAL CATHETER WAS BEING USED FOR AN INTRAOPERATIVE CHOLANGIOGRAM THE RUBBER PLASTIC PIECE FROM THE INTRADUCER CATHETER DISLODGED AND WAS FOUND INTACT INTRA-ABDOMINALLY BY THE SURGEON. THE FOREIGN BODY WAS RETRIEVED INTACT AND IT WAS COMPARED WITH AN INTACT TAUT INTRADUCER SHOWING BOTH RUBBER PLASTIC PIECES WERE INTACT AND IN SIZE LENGTH AND WIDTH. THERE WAS NO PATIENT INJURY.