BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BBL

    MDR report key: 3816571 · Received May 9, 2014

    Report

    Report Number
    3816571
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 9, 2014
    Manufacturer
    BD
    Product Code
    JSG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    THE LABORATORY HAS RECEIVED APPROXIMATELY 110 CDC ANAEROBE 5% SHEEP BLOOD AGAR PREPARED PLATED MEDIA THAT WERE CONTAMINATED WITH LISTERIA MONOCYTOGENES. MOST OF THE PLATES HAVE ONLY ONE COLONY BUT SOME PLATES HAVE SEVERAL COLONIES. THE COLONIES CAN BE SEEN ON THE CONTAMINATED PLATES THROUGH THE SEALED PACKAGES STRAIGHT OUT OF THE BOX WITH NO INCUBATION INVOLVED.====================== MANUFACTURER RESPONSE FOR PREPARED PLATED MEDIA: CDC ANAEROBE 5% SHEEP BLOOD AGAR, BBL CDC ANAEROBE 5% SHEEP BLOOD AGAR (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282232 BBL CULTURE MEDIA, SELECTIVE JSG BD * 4077423

    Patients

    Seq Age Sex Outcome Treatment
    1 *