BD AFFIRM¿ VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM

Additional Manufacturer Narrative

MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. LOT #: NO LOT # PROVIDED. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: BD MOLECULAR QUALITY INVESTIGATED AN END USER, AFFIRM ATTS GLASS USER INJURY (FINGER PUNCTURE) DURING DISPENSING 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. INVESTIGATION CONCLUSION: COMPLAINT NOT CONFIRMED. ROOT CAUSE DESCRIPTION: END USER NOT FOLLOWING PROCEDURE. RATIONALE: COMPLAINT NOT CONFIRMED. NO TREND (<3 COMPLAINTS AGAINST INDICATED FAILURE MODE FOR GIVEN MONTH).

Description of Event or Problem

THIS REPORT REPRESENTS PATIENT 1 OF 2: IT WAS REPORTED WHILE USING A BD AFFIRM¿ VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM THE LAB TECHNICIAN BROKE THE GLASS AMPULE WITH A REAGENT DROPPER. HOWEVER, AFTER BREAKING THE GLASS AMPULE THE LAB TECHNICIAN REMOVED THE CAP AND POURED THE CONTENTS INTO A SAMPLE COLLECTION TUBE. THE TECHNICIAN DID NOT NOTICE THE GLASS SHARDS IN THE TUBE AND CUT THEIR FINGERS WHILE SQUEEZING THE COLLECTION TUBE. THE LAB TECHNICIAN WAS EXPOSED TO PATIENT SAMPLE THROUGH THE CUTS IN THEIR FINGERS. THE LAB TECHNICIAN WAS TREATED WITH FIRST AID ON SITE WHICH INCLUDED RINSING THE INJURY SITE AND BANDAGING THEIR WOUNDS. POST EXPOSURE, THE LAB TECHNICIAN WAS TESTED AND THEN MONITORED FOR (B)(6). NO INDICATION WAS GIVEN THAT THE PATIENT HAD CONTRACTED A BLOODBORNE ILLNESS FROM THE EXPOSURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS TWO INJURIES DUE TO THE GLASS AMPULE IN THE ATTS KIT. THE CUSTOMER STATES THEY WERE RECEIVING SAMPLES FROM COLLECTION SITES WHERE THE COLLECTION SITES HAVE CORRECTLY BROKEN THE GLASS AMPULE USING THE REAGENT DROPPER BUT HAVE REMOVED THE CAP AND POURED THE CONTENTS INTO THE TRANSPORT/SAMPLE COLLECTION TUBE WITH THE PATIENT SPECIMEN. THE LAB EXPLAINS THAT THEY DID NOT NOTICE THE GLASS SHARDS INSIDE THE TUBE AND CUT THEIR FINGERS WHEN SQUEEZING THE COLLECTION TUBES AS WELL AS WHEN ADDING THE FILTER TIP...END USERS REQUIRED ONLY ON-SITE FIRST AID, INCLUDING RINSING THE PUNCTURE SITE AND ADHERING A BAND AID...END USERS WERE POTENTIALLY EXPOSED TO PATIENT BODILY FLUIDS AND ARE BEING MONITORED AND TESTED FOR (B)(6)."