BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAN AEROBIC CULTURE BOTTLES

    MDR report key: 111574 · Received August 7, 1997

    Report

    Report Number
    MW1011852
    Event Type
    Malfunction
    Date Received
    August 7, 1997
    Date of Event
    August 5, 1997
    Report Date
    August 6, 1997
    Manufacturer
    ORGANON TEKNIKA CORP.
    Product Code
    JSC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BLOOD WAS DRAWN FROM THIS PT AND PLACED IN A FAN BLOOD CULTURE BOTTLE. WHEN THE BOTTLE WAS RECEIVED IN THE LAB, THE BOTTOM WAS NOTED TO BE YELLOW INDICATING A POSITIVE BOTTLE. LESS THAN 1 HR. HAD ELAPSED FROM THE TIME OF COLLECTION TO THE TIME OF RECEIPT IN THE LAB. RPTR CONCLUDED THAT THE BOTTLE MUST HAVE BEEN CONTAMINATED PRIOR TO INOCULATION. THIS APPEARS TO BE A DEFECTIVE PRODUCT FROM THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAN AEROBIC CULTURE BOTTLES BLOOD CULTURE BOTTLE JSC ORGANON TEKNIKA CORP. FAN AEROBIC BOTTLE 203899

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Other