BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANAEROBIC CULTURE BOTTLES

    MDR report key: 153510 · Received February 27, 1998

    Report

    Report Number
    MW1013080
    Event Type
    Malfunction
    Date Received
    February 27, 1998
    Date of Event
    January 21, 1998
    Report Date
    February 17, 1998
    Manufacturer
    ORGANON TEKNIKA CORP.
    Product Code
    JSL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO BLOOD CULTURE BOTTLES HAVE THE SAME BAR-CODED NUMBER. THESE TWO BOTTLES BELONG TO THE SAME LOT AND HAVE AN EXPIRATION DATE 09/19/98. USER BECAME AWARE OF SITUATION WHEN THE BLOOD CULTURE MACHINE INDICATED A WARNING CONCERNING THE SAME BAR CODE FOR TWO DIFFERENT PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANAEROBIC CULTURE BOTTLES BLOOD CULTURE BOTTLE JSL ORGANON TEKNIKA CORP. 59269 208414

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other