BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT MP CULTURE BOTTLES

    MDR report key: 960979 · Received April 30, 2007

    Report

    Report Number
    3002769706-2007-00002
    Event Type
    Malfunction
    Date Received
    April 30, 2007
    Date of Event
    February 26, 2007
    Report Date
    April 30, 2007
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    JTA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BACT/ALERT MP PROCESS SYSTEM CONSISTS OF THE BACT/ALERT MP PROCESS BOTTLE WITH A REMOVABLE CLOSURE USED IN CONJUNCTION WITH THE MB/BACT ANTIOBIOTIC SUPPLEMENT (AND/OR THE MB/BACT RECONSTITUTION FLUID). THE BACT/ALERT MP PROCESS SYSTEM IS DESIGNED FOR USE WITH THE MB/BACT OR THE BACT/ALERT 3D MYCOBACTERIA DETECTION SYSTEMS FOR RECOVERY AND DETECTION OF MYCOBACTERIA FROM STERILE BODY SPECIMENS OTHER THAN BLOOD, AND FROM DIGESTED-DECONTAMINATED CLINICAL SPECIMENS. HOWEVER, THERE IS THE POTENTIAL FOR ADVERSE EVENTS WERE THIS TO REOCCUR DUE TO THE FACT THAT SOME MYCOBACTERIA SAMPLES CAN HAVE SIGNIFICANT HEALTH EFFECTS AND IF THE SAMPLE AEROSOLIZED, AS IT MAY HAVE IN THIS CASE, THE LIKELIHOOD OF ORGANISM TRANSMISSION IS SIGNIFICANTLY INCREASED.

    Description of Event or Problem · 1

    A GLASS BACT/ALERT MP CULTURE BOTTLE WAS FOUND BROKEN IN A BACT/ALERT INCUBATOR. THE BROKEN BOTTLE SAMPLE HAD FLAGGED POSITIVE FOR MYCOBACTERIUM AND WHEN UNLOADED, IT WAS NOTICED THAT ALL OF THE CONTENTS HAD EVAPORATED RESULTING IN POTENTIAL AEROSOLIZATION OF THE ORGANISM. THERE WERE NO ADVERSE PATIENT OR HEALTHCARE WORKER EVENTS INDICATED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACT MP CULTURE BOTTLES MICROBIAL GROWTH MONITOR JTA BIOMERIEUX, INC. 251010 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other