AFFIRM VPIII MICROBIAL IDENTIFICATION TESTS

Additional Manufacturer Narrative

THE BD AFFIRM VPIII MICROBIAL IDENTIFICATION TEST IS A DNA PROBE TEST INTENDED FOR USE IN THE DETECTION AND IDENTIFICATION OF CANDIDA SPECIES, GARDNERELLA VAGINALIS AND TRICHOMONAS VAGINALIS NUCLEIC ACID IN VAGINAL FLUID SPECIMENS FROM PATIENTS WITH SYMPTOMS OF VAGINITIS/VAGINOSIS. BD HAS APPROVED THE USE OF THE ROBOGRIP¿ TOOL TO ASSIST IN FACILITATING THE EXPRESSION OF THE CONTENTS OF THE AFFIRM SAMPLE COLLECTION TUBE (SCT) INTO THE AFFIRM REAGENT CASSETTE FOR PROCESSING. THIS IS ACHIEVED BY PROVIDING LEVERAGE AND TRANSFERRING PRESSURE FROM THE USER¿S THUMB TO THE USER¿S HAND AND STRONGER MUSCLES OF THE LOWER ARM. THIS TOOL (WITH ACCOMPANYING INSTRUCTIONS) IS AVAILABLE TO ANY AFFIRM END USER UPON REQUEST. THIS CUSTOMER WAS SENT THE ROBOGRIP¿ TOOL IN ORDER TO MITIGATE ANY FURTHER ERGONOMIC ISSUES IN RESPONSE TO THIS COMPLAINT. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS ASSOCIATED WITH ERGONOMIC ISSUES ON AFFIRM. (B)(4). DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

THE CUSTOMER IS REPORTING A STRAIN TO THE RIGHT THUMB DUE TO THE REPETITIVE MOTION OF SQUEEZING THE SAMPLE VIAL. THE CUSTOMER IS USING A THUMB BRACE AND CONTACTED THEIR EMPLOYEE HEALTH DEPARTMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED REGARDING THE EMPLOYEES STRAIN.