BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACTEC MYCO/F-SPUTA CULTURE VIAL

    MDR report key: 91416 · Received May 15, 1997

    Report

    Report Number
    1119779-1997-00006
    Event Type
    Malfunction
    Date Received
    May 15, 1997
    Date of Event
    April 29, 1997
    Report Date
    May 14, 1997
    Manufacturer
    BECTON DICKINSON MICROBIOLOGY SYSTEMS
    Product Code
    JSC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOUR VIALS FROM THIS LOT HAVE LEAKED AFTER ENTRY INTO THE INSTRUMENT. THEY APPEAR TO BE LEAKING FROM THE CAP END OF THE VIAL. NO DEATH OR SERIOUS INJURY HAS OCCURRED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACTEC MYCO/F-SPUTA CULTURE VIAL CULTURE MEDIA JSC BECTON DICKINSON MICROBIOLOGY SYSTEMS NA 0157A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other