BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT FN CULTURE BOTTLES

    MDR report key: 969453 · Received December 21, 2007

    Report

    Report Number
    3002769706-2007-00009
    Event Type
    Malfunction
    Date Received
    December 21, 2007
    Date of Event
    November 23, 2007
    Report Date
    December 21, 2007
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    JTA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THIS INCIDENT HAS BEEN INITIATED. THE CUSTOMER HAS BEEN SENT A COPY OF KC5-GCS INFO 2005-02 "RECOMMENDATIONS FOR SUBCULTURING POSITIVE BACT/ALERT CULTURE BOTTLES" WITH RECOMMENDATIONS AND INSTRUCTIONS FOR VENTING BOTTLES WITH HIGH GAS PROCEDURES. THE PACKAGE INSERT CAUTIONS THAT "POSITIVE CULTURE BOTTLES SHOULD BE TRANSIENTLY VENTED...TO RELEASE ANY GAS PRODUCED DURING MICROBIAL METABOLISM." THE USER DOES NOT CLAIM ANY INJURY DUE TO THE EVENT ALTHOUGH SHE WAS SPLASHED WITH BLOOD WHICH HAD REGISTERED POSITIVE WITH E. COLI. NO MEDICAL TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    THE BOTTOM OF AN INOCULATED BACT/ALERT FN PLASTIC BOTTLE REMOVED FROM THE INCUBATOR BROKE INTO PIECES WHEN IT WAS SET OUT TO COOL DOWN. THE CUSTOMER, WHO WAS SPLATTERED WITH BLOOD WHICH HAD TESTED POSITIVE WITH E. COLI, WAS NOT HARMED AND NO MEDICAL TREATMENT WAS REQUIRED. THERE IS A POTENTIAL FOR AN ADVERSE EVENT WERE THIS TO RECUR; THE USER COULD BE EXPOSED TO BACTERIA SAMPLES THAT CAN HAVE SIGNIFICANT HEALTH EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACT/ALERT FN CULTURE BOTTLES MICROBIAL GROWTH MONITOR JTA BIOMERIEUX, INC. 259793 1018006

    Patients

    Seq Age Sex Outcome Treatment
    1 YR