CORE TRUMPET SUCTION /IRRIGATION

Additional Manufacturer Narrative

CONMED CORPORATION RECEIVED ONE (1) UNOPENED PACKAGE CONTAINING THE CORE TRUMPET SUCTION/IRRIGATION DEVICE FOR EVALUATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT NOTED THERE ARE SMALL CREASES IN THE SEALING AREA ON THE STRAIGHT SEAL OF THE PACKAGE (SEAL OPPOSITE CHEVRON SEAL). IT APPEARS THERE ARE SMALL CHANNELS WITHIN THE CREASES THAT PASS THROUGH THE SEAL. THIS DEVICE WAS TRANSFERRED TO THE PACKAGING ENGINEERING TEST LAB FOR DYE LEAK TESTING. THE PACKAGING FAILED DYE LEAK TESTING, ON (B)(6) 2016, CONFIRMING THERE WAS A BREACH IN THE STERILITY OF THIS DEVICE. THIS LOT WAS MANUFACTURED ON 26-JAN-2015. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT FOUND NO NCRS AND NO DISCREPANCIES NOTED DURING THE MANUFACTURING PROCESS. (B)(4). PRELIMINARY INVESTIGATION REVEALED THE MOST PROBABLE CAUSE OF THE CREASES FOUND IN THE SEAL IS MANUFACTURING RELATED. THE MANUFACTURING SUPERVISORS HAVE BEEN MADE AWARE OF THIS REPORTED PROBLEM AND AN INVESTIGATION HAS BEEN REQUESTED. TO DATE, THERE HAVE BEEN NO SERIOUS INJURIES OR DEATH RELATED TO THIS REPORTED PROBLEM. TO PREVENT FUTURE RECURRENCES, AN INVESTIGATION HAS BEEN OPENED TO ADDRESS THIS ISSUE.

Description of Event or Problem

THE DISTRIBUTOR IN (B)(6) REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, "INSUFFICIENT HEAT SEAL" WAS FOUND IN THE SEALING AREA OF A STERILE PACKAGE CONTAINING THE CORE TRUMPET SUCTION /IRRIGATION DEVICE. TESTING RESULTS CONFIRMED THAT THE RETURNED PACKAGE EXHIBITING CREASES IN THE FINAL MANUFACTURING SEAL FAILED THE DYE LEAK TEST ON (B)(6) 2016. THERE WAS NO PATIENT INVOLVEMENT WITH THIS REPORTED DEVICE, AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION AT THE DISTRIBUTOR FACILITY PRIOR TO DISTRIBUTION TO AN END-USER.