BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHEEP BLOOD, 100 ML

    MDR report key: 542846 · Received July 1, 2004

    Report

    Report Number
    MW1032726
    Event Type
    Malfunction
    Date Received
    July 1, 2004
    Date of Event
    June 8, 2004
    Report Date
    July 1, 2004
    Manufacturer
    BECTON-DICKINSON
    Product Code
    JSK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SHIPMENT OF SHEEP BLOOD WAS RECEIVED IN THE LAB IN 2004. THIS IS USED TO INOCULATE NON-BLOOD SAMPLES -I.E. FLUIDS- IN BLOOD CULTURE MEDIA TO ENHANCE GROWTH AND PROVIDE A SUPPLEMENT. IT WAS SET-UP AS A CONTROL TO DETERMINE IF THERE WERE ANY CONTAMINATES ALONG WITH THE PT. NOTHING WAS ISOLATED UNTIL 2 WEEKS LATER A GRAM NEGATIVE ROD. PRELIMINARY TESTING DONE IN HOUSE. SUSPICION OF BRUCELLA. SENT TO THE STATE BOARD OF HEALTH (SBOH). SBOH IDENTIFIED BRUCELLA SPECIES. SBOH SENT TO CDC FOR SPECIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHEEP BLOOD, 100 ML * JSK BECTON-DICKINSON * 4155326

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other