BD AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM

Additional Manufacturer Narrative

MEDICAL DEVICE LOT #: LOT # FOR SWAB WAS NOT PROVIDED, HOWEVER, THE LOT FROM THE SAMPLING KIT WAS. LOT# B01C269M. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4). INVESTIGATION SUMMARY: BD MOLECULAR QUALITY INITIATED INVESTIGATION ON THE CUSTOMER REPORT REGARDING AN INCIDENT WHERE DURING PATIENT SPECIMEN COLLECTION AN AFFIRM SWAB HEAD DETACHED. QUALITY INVESTIGATION REQUIRED VENDOR INVESTIGATION. OUR SWAB MANUFACTURER (VENDOR) REVIEWED THE BATCH HISTORY RECORDS FOR THE BATCH IN QUESTION AND NO DISCREPANCIES WERE NOTED. THE VENDOR PERFORMED INSPECTIONS AND TESTING OF RETENTION MATERIALS FROM THE REPORT BATCH AND NO FAILURES WERE ENCOUNTERED. OUR VENDOR WAS UNABLE TO DUPLICATE THE REPORT. THE VENDOR REVIEWED THE PAST YEAR YEARS OF COMPLAINTS AGAINST THE SWAB PRODUCT AND THERE WERE NO COMPLAINTS RELATED TO SWAB HEAD DETACHMENT. BD REVIEWED THE PAST YEAR OF COMPLAINTS AND THERE ARE NO SIMILAR COMPLAINTS, THUS WE BELIEVE THIS TO BE AN ISOLATED INCIDENT. BD MOLECULAR QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH AFFIRM SWAB HEAD DETACHMENT. THERE WAS NO CORRECTIVE ACTION TAKEN AT THIS TIME.

Description of Event or Problem

IT WAS REPORTED WHILE USING BD AFFIRM¿ VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM THE SWAB TIP BROKE OFF IN PATIENT'S VAGINA. THERE WAS NO REPORT OF PATIENT IMPACT.