AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT

Description of Event or Problem

THE CUSTOMER REPORTED THAT WHILE PROCESSING AN AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT TUBE WHICH WAS INOCULATED WITH PATIENT SAMPLE, A SHARD OF GLASS PIERCED THROUGH THE PLASTIC AND CUT A TECHNICIAN'S FINGER. THE WOUND WAS CLEANED OUT WITH SOAP AND WATER, A BANDAGE WAS APPLIED AND THE TECHNICIAN SOUGHT MEDICAL ATTENTION FOR POSSIBLE EXPOSURE TO BODY FLUID. THE PATIENT, WHO WAS THE SOURCE OF THE SAMPLE, AND THE TECHNICIAN WERE BOTH TESTED FOR (B)(6), (B)(6) AND (B)(6). ALL TESTS WERE (B)(6). THE CUSTOMER REPORTS THAT THE TECHNICIAN IS DOING FINE.

Additional Manufacturer Narrative

AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT 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 VPII AMBIENT TEMPERATURE TRANSPORT SYSTEM (ATTS) SHOULD BE USED WITH THOSE SPECIMENS WHERE TRANSPORT TIMES ARE EXPECT TO EXCEED 1 H AT AMBIENT TEMPERATURE (15-30C) OR 4 H AT REFRIGERATED TEMPERATURES (2-8C). BD MOLECULAR QUALITY INITIATED INVESTIGATION ON THE CUSTOMER REPORT REGARDING A ATTS GLASS INJURY WHEN SQUEEZING AN AFFIRM SPECIMEN. REVIEW OF THE PACKAGE INSERT CONFIRMS THAT THE END USER WAS LIKELY NOT FOLLOWING THE CORRECT ATTS COLLECTION PROCEDURE. WHEN USING THE ATTS, THE END USER IS INSTRUCTED TO BREAK THE GLASS ATTS AMPULE WITHIN IT'S PLASTIC PROTECTIVE SHEATH AND DISPENSE THE ATTS SOLUTION INTO THE SPECIMEN TUBE. IN THIS CASE, THE GLASS WAS FOUND INSIDE THE SPECIMEN TUBE. GLASS IN THE SPECIMEN TUBE SHOULD NOT BE POSSIBLE UNLESS THE END USER REMOVED THE ATTS CAP INCORRECTLY POURS THE GLASS INTO THE SPECIMEN TUBE. REVIEW OF THE LAST YEAR OF COMPLAINT DATA REVEALS THIS IS AN ISOLATED INCIDENT. BD MOLECULAR QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH ATTS GLASS INJURY. THERE WAS NO CORRECTIVE ACTION TAKEN AT THIS TIME.