BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACTEC MYCO/F-SPUTA CULTURE VIAL

    MDR report key: 89695 · Received May 7, 1997

    Report

    Report Number
    1119779-1997-00004
    Event Type
    Malfunction
    Date Received
    May 7, 1997
    Date of Event
    April 18, 1997
    Report Date
    April 30, 1997
    Manufacturer
    BECTON DICKINSON MICROBIOLOGY SYSTEMS
    Product Code
    JSC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT 6 TO 7 BOTTLES WITH CRACKED GLASS AROUND SEAL OF BOTTLE. SOME BOTTLES LEAKED WHEN PLACED INTO INSTRUMENT. PT SPECIMENS ARE NEGATIVE TO DATE FOR AFB. NO DEATH OR SERIOUS INJURY 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