BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACTEC MYCO/F-SPUTA CULTURE VIAL

    MDR report key: 96393 · Received June 4, 1997

    Report

    Report Number
    1119779-1997-00008
    Event Type
    Malfunction
    Date Received
    June 4, 1997
    Date of Event
    May 28, 1997
    Report Date
    May 30, 1997
    Manufacturer
    BECTON DICKINSON MICROBIOLOGY SYSTEMS
    Product Code
    JSC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED LEAKING AROUND CRIMPING OF 6 VIALS AFTER INOCULATION OF SPECIMEN. CUSTOMER REPORTED SEAL APPEARED LOOSE AND NOT TIGHTLY SEALED. 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