TAUT INTRADUCERS 10/BX 8RF X 3.5

Additional Manufacturer Narrative

(B)(4). THE CUSTOMER RETURNED ONE UNIT PI-104 TAUT INTRADUCERS 10/BX 8RF X 3.5 FOR INVESTIGATION. THE SAMPLE WAS RETURNED IN ITS ORIGINAL PACKAGING. THE RETURNED SAMPLE WAS VISUALLY INSPECTED WITH AND WITHOUT MAGNIFICATION. VISUAL INSPECTION REVEALED THAT THE BOTTOM OF THE PACKAGE WAS UNSEALED AND HAD TAPE ON IT TO KEEP IT CLOSED. THERE WAS A STAPLE NEAR THE TOP OF THE PACKAGE, OUTSIDE OF THE STERILE BARRIER. RESIDUE WAS PRESENT ON THE PACKAGE AT THE BOTTOM OF THE PACKAGE THAT PROVIDES EVIDENCE THAT THE PACKAGE WAS SEALED AT ONE POINT. THE RETURNED SAMPLE WAS SENT TO THE MANUFACTURING SITE FOR FURTHER EVALUATION. ACCORDING TO THE INVESTIGATION, "THE SEALING AREA IS COMPLETE AND AT LEAST 3MM (1.8") WIDE ALL AROUND THE PERIMETER OF THE PACKAGE COMPLYING WITH QIP-036TEC REV. 11." "TO VERIFY THAT THE SEAL IS INADEQUATE, IT IS NECESSARY TO PERFORM THE BURST TEST BUT SINCE THE PACKAGE IS OPEN, IT'S NOT POSSIBLE TO PERFORM THE TEST AND THEREFORE THE FAILURE MODE "STERILITY BREACH" CANNOT BE CONFIRMED." THE BURST TEST DATA WAS REVIEWED FOR THE LOT NUMBER OF THE SAMPLE IN QUESTION AS WELL AS THE FIVE LOT NUMBERS MANUFACTURED RIGHT BEFORE AND RIGHT AFTER THE LOT NUMBER IN QUESTION. UPON REVIEW OF THE DATA, IT WAS CONFIRMED THAT ALL LOT NUMBERS REVIEWED PASSED THE BURST TEST. QIP-036TEC REV. 11 WAS REVIEWED AS PART OF THE MANUFACTURING SITE'S INVESTIGATION. THE REPORTED COMPLAINT OF "STERILITY BREACH" WAS NOT CONFIRMED BASED UPON THE SAMPLES RECEIVED. VISUAL INSPECTION REVEALED THAT THE BOTTOM OF THE PACKAGE WAS UNSEALED AND HAD TAPE ON IT TO KEEP IT CLOSED. THERE WAS A STAPLE NEAR THE TOP OF THE PACKAGE, OUTSIDE OF THE STERILE BARRIER. RESIDUE WAS PRESENT ON THE PACKAGE AT THE BOTTOM OF THE PACKAGE THAT PROVIDES EVIDENCE THAT THE PACKAGE WAS SEALED AT ONE POINT. THE RETURNED SAMPLE WAS SENT TO THE MANUFACTURING SITE FOR FURTHER EVALUATION. ACCORDING TO THE INVESTIGATION, "THE SEALING AREA IS COMPLETE AND AT LEAST 3MM (1.8") WIDE ALL AROUND THE PERIMETER OF THE PACKAGE COMPLYING WITH QIP-036TEC REV. 11." "TO VERIFY THAT THE SEAL IS INADEQUATE, IT IS NECESSARY TO PERFORM THE BURST TEST BUT SINCE THE PACKAGE IS OPEN, IT'S NOT POSSIBLE TO PERFORM THE TEST AND THEREFORE THE FAILURE MODE "STERILITY BREACH" CANNOT BE CONFIRMED." THE BURST TEST DATA WAS REVIEWED FOR THE LOT NUMBER OF THE SAMPLE IN QUESTION AS WELL AS THE FIVE LOT NUMBERS MANUFACTURED RIGHT BEFORE AND RIGHT AFTER THE LOT NUMBER IN QUESTION. UPON REVIEW OF THE DATA, IT WAS CONFIRMED THAT ALL LOT NUMBERS REVIEWED PASSED THE BURST TEST. IT COULD NOT BE DETERMINED HOW OR WHEN THE PACKAGE WAS OPENED, BUT IT DOES NOT APPEAR TO BE A MANUFACTURING RELATED ROOT CAUSE.

Description of Event or Problem

IT WAS REPORTED THAT DURING PRETEST, THE OR REALIZED THAT THE STERILE PACKAGE HAD BEEN COMPROMISED. A NEW UNIT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT.

Additional Manufacturer Narrative

(B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT TAUT INTRADUCERS 10/BX 8RF X 3.5, LOT #73K1800295. 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 THAT DURING PRETEST, THE OR REALIZED THAT THE STERILE PACKAGE HAD BEEN COMPROMISED. A NEW UNIT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT.