AFFIRM¿ VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM

Additional Manufacturer Narrative

AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM IS A STERILE READY-TO-USE SYSTEM INTENDED FOR THE COLLECTION, TRANSPORT AND PRESERVATION OF VAGINAL SPECIMENS FOR USE ONLY WITH THE AFFIRM VPIII MICROBIAL IDENTIFICATION TEST. THE AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM (ATTS) SHOULD BE USED WITH THOSE SPECIMENS WHERE TRANSPORT TIMES ARE EXPECTED TO EXCEED 1 H AT AMBIENT TEMPERATURE (15 ¿ 30°C) OR 4 H AT REFRIGERATED TEMPERATURES (2 ¿ 8°C). BD MOLECULAR QUALITY INITIATED INVESTIGATION ON 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. QUALITY INVESTIGATION REQUIRED REVIEW OF THE AFFIRM ATTS PACKAGE INSERT AND AFFIRM COLLECTION POSTER. PER REVIEW OF THE AFFIRM PACKAGE INSERT & COLLECTION POSTER, 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 AMPOULE (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 WILL UPDATE THE AFFIRM COLLECTION POSTER TO PROVIDE FURTHER CLARIFICATION ON THE INSTRUCTIONS OF USE WITH AFFIRM ATTS. BD MOLECULAR QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH AFFIRM ATTS GLASS INJURY. DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

THE CUSTOMER REPORTED THAT WHILE PROCESSING THE SPECIMEN TRANSPORT TUBE FROM A AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM, GLASS PIERCED THROUGH THE TUBE AND CAUSED A CUT ON A TECHNICIAN'S FINGER. THE TUBE WAS INOCULATED WITH PATIENT SPECIMEN. BASIC FIRST AID WAS APPLIED AND THE TECHNICIAN WAS SENT TO A MEDICAL PROVIDER. TESTING FOR BLOOD BORNE PATHOGEN EXPOSURE WAS PERFORMED. ONE WEEK AFTER THE INJURY, THE TECH FOLLOWED-UP WITH THE MEDICAL PROVIDER AND THE WOUND HEALED. NO FURTHER INFORMATION PROVIDED.