BD AFFIRM¿ VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM

Additional Manufacturer Narrative

MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. NO LOT # PROVIDED. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: BD MOLECULAR QUALITY INVESTIGATED AN END USER, AFFIRM ATTS GLASS USER INJURY (FINGER PUNCTURE) DURING DISPENSE OF SPECIMEN AT AN AFFIRM TESTING FACILITY. IT WAS CONFIRMED THAT THE END USER FOUND GLASS IN THE SPECIMEN COLLECTION TUBE. IT WAS DETERMINED THAT THE AFFIRM COLLECTION SITE WAS NOT FOLLOWING THE AFFIRM ATTS PACKAGE INSERT OR AFFIRM COLLECTION POSTER INSTRUCTIONS. THE COLLECTION SITE WAS CRUSHING THE ATTS GLASS AMPULE (AS INSTRUCTED), OPENING THE ATTS CAP AND POURING THE GLASS INTO THE AFFIRM SAMPLE COLLECTION TUBE (NOT INSTRUCTED). THE AFFIRM PACKAGE INSERT AND AFFIRM COLLECTION POSTER DOES NOT INSTRUCT COLLECTION SITES TO OPEN THE ATTS VIAL AND POUR THE GLASS INTO THE COLLECTION TUBE. BD HAS COMPLETED AN UPDATE TO THE AFFIRM COLLECTION POSTER TO PROVIDE FURTHER CLARIFICATION ON THE INSTRUCTIONS FOR USE WITH AFFIRM ATTS. BD MOLECULAR QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH AFFIRM ATTS GLASS INJURY.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING A BD AFFIRM¿ VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM THE TECHNICIAN WAS PLACING THE SAMPLE TUBE INTO THE DEVICE WHEN SHARP PIECES OF THE GLASS AMPULE PENETRATED THE WALL OF THE DEVICE AND CUT THE FINGER OF THE TECHNICIAN RESULTING IN EXPOSURE TO PATIENT SAMPLE. THE TECHNICIAN RECEIVED A MEDICAL EVALUATION AND WAS TREATED FOR EXPOSURE TO BLOODBORNE PATHOGENS AT AN URGENT CARE FACILITY.