NOZZLE,STRAIGHT,ABC,DISP/20

Additional Manufacturer Narrative

THE REPORTED 70 DEVICES WERE RETURNED TO CONMED IN THEIR ORIGINAL UNOPENED PACKAGES FOR EVALUATION. ALL 70 DEVICES WERE VISUALLY INSPECTED. FIFTY-SEVEN (57) DEVICES WERE OBSERVED TO HAVE A CHANNEL IN THE CENTER OF THE CHEVRON SEAL. THIRTEEN (13) SAMPLES WERE OBSERVED TO HAVE A SEAL AREA LESS THAN 1/4" AT THE CENTER OF THE CHEVRON SEAL. PER ESTABLISHED AQL LEVEL, 13 OF THESE 70 DEVICES WERE SELECTED AT RANDOM AND A PACKAGING ENGINEER PERFORMED FURTHER TESTING. IT WAS DETERMINED THAT 8 DEVICES HAD A BREACH IN STERILITY AND 5 HAD A SEAL AREA LESS THAN ¼" ON THE CHEVRON SEAL THAT DID NOT COMPROMISE STERILITY. MOVEMENT OF THE DEVICE WITHIN THE POUCH IS RESTRICTED DUE TO THE RUBBER COMPONENTS THAT INTERACT WITH PET SIDE OF THE POUCH; THEREFORE, THE PACKAGING SYSTEM WAS COMPROMISED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND THE DEVICES WITHIN THIS LOT WERE VERIFIED TO HAVE BEEN PRODUCED ACCORDING TO CURRENT AND APPROVED PROCEDURES AND MATERIAL SPECIFICATIONS. NON-CONFORMANCES REGARDING THE PRODUCT'S IDENTITY, QUALITY, SAFETY, EFFECTIVENESS OR PERFORMANCE WERE NOT IDENTIFIED DURING MANUFACTURE. NO PRIOR INCIDENCES HAVE BEEN REPORTED AGAINST THIS LOT OF 800 UNITS. A TWO-YEAR HISTORICAL COMPLAINT REVIEW REVEALED NO SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS DEVICE. THIS REPORTED PACKAGING ISSUES WERE OBVIOUS TO THE DISTRIBUTOR, PROMPTING THE RETURN OF THE DEVICES FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT. AS WITH ALL MEDICAL DEVICES, EXAMINATION OF THE PRODUCT OCCURS MULTIPLE TIMES PRIOR TO USE. GOOD CLINICAL PRACTICE WOULD INCLUDE EXAMINATION AND VERIFICATION OF THE ORIGINAL PACKAGING AND ITS LABELING TO ENSURE BOTH ARE INTACT. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING WARNING. IF PACKAGING HAS BEEN OPENED/DAMAGED OR ALTERED, DO NOT USE THE PRODUCT AND CONTACT THE MANUFACTURER IMMEDIATELY. THIS INCIDENT HAS BEEN ESCALATED FOR FURTHER INVESTIGATION AND WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM.

Description of Event or Problem

A CONMED REPRESENTATIVE REPORTED THE DISTRIBUTOR IN (B)(4) REJECTED 70 130343 ABC NOZZLES DUE TO SEALING ISSUES. IN THIS INSTANCE, THERE WAS NO PATIENT INVOLVEMENT AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION PRIOR TO DISTRIBUTION TO AN END-USER. THE REPORT IS RAISED ON THE BASIS OF A DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.