BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT SA

    MDR report key: 2760187 · Received April 18, 2007

    Report

    Report Number
    2760187
    Event Type
    Malfunction
    Date Received
    April 18, 2007
    Date of Event
    March 20, 2007
    Report Date
    April 18, 2007
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LIO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BOTTLE OF AEROBIC BACT/ALERT SA HAD NO VACUUM AND INSIDE OF VIAL HAD VISIBLE GREY MATTER RUNNING DOWN INSIDE OF VIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACT/ALERT SA AEROBIC CULTURE VIAL LIO BIOMERIEUX, INC. 1015088

    Patients

    Seq Age Sex Outcome Treatment
    1 NA