BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT MP CULTURE BOTTLES

    MDR report key: 1065518 · Received June 25, 2008

    Report

    Report Number
    3002769706-2008-00002
    Event Type
    Malfunction
    Date Received
    June 25, 2008
    Date of Event
    May 27, 2008
    Report Date
    June 20, 2008
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    JTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER HAD DISINFECTED THE PLASTIC BACT/ALERT MP CULTURE BOTTLE WITH BIOCLEANSE (TEKNOM), A DISINFECTANT, WHICH ACCORDING TO TEKNON'S APPLICATION CHART, IS NOT RECOMMENDED FOR THE USE ON POLYCARBONATE BOTTLES. BIOMERIEUX, INC. HAS INVESTIGATED THE INTERACTION OF SOME DISINFECTANTS ON ITS POLYCARBONATE BOTTLES AND HAS ISSUED A NOTICE ALERTING USERS TO READ THE DISINFECTANT'S LABEL TO DETERMINE COMPATIBILITY WITH POLYCARBONATE BOTTLES. BIOMERIEUX HAS ALSO MODIFIED ITS PACKAGE INSERT WITH A CAUTION ABOUT POLYCARBONATES AND CHOICE OF DISINFECTANTS BY THE USER.

    Description of Event or Problem · 1

    A PLASTIC BACT/ALERT MP CULTURE BOTTLE WAS FOUND BROKEN IN THE BACT/ALERT INCUBATOR. AFB STAIN INDICATED THAT ITS CONTENTS WERE NEGATIVE. THERE WERE NO ADVERSE EVENTS NOTED AS A RESULT OF THIS INCIDENT. THE LAB WAS CLOSED AND A FORMALDEHYDE GAS STERILIZATION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACT/ALERT MP CULTURE BOTTLES MICROBIAL GROWTH MONITOR JTA BIOMERIEUX, INC. 1018685

    Patients

    Seq Age Sex Outcome Treatment
    1