BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2441080 · Received January 31, 2012

    Report

    Report Number
    2441080
    Event Type
    Malfunction
    Date Received
    January 31, 2012
    Date of Event
    January 20, 2012
    Report Date
    January 31, 2012
    Manufacturer
    BECTON DICKINSON
    Product Code
    JSD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE TRYPTICASE SOY BROTH (TSB) WAS USED TO PLATE A CHEST ABSCESS SWAB SPECIMEN AND TO PERFORM A GRAM STAIN. THERE WAS NO GROWTH OF GRAM POSITIVE BACILLI ON THE CULTURE PLATE. THE GRAM STAINED SLIDE WAS PULLED AND REVIEWED. IT WAS DISCOVERED AFTER GRAM STAINING THE TSB ALONE, THAT THE SOURCE OF THE GRAM POSITIVE BACILLI WAS THE BROTH ITSELF. THE GRAM STAIN RESULT WAS CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * TRYPTICASE SOY BROTH JSD BECTON DICKINSON * 1245773

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR