BEUDAMED
    FDA Adverse Event Other Summary report: N

    BBL MGIT MYCOBACTERIA GROWTH INDICATOR TUBE

    MDR report key: 1375597 · Received February 23, 2009

    Report

    Report Number
    1119779-2009-00005
    Event Type
    Other
    Date Received
    February 23, 2009
    Date of Event
    February 13, 2009
    Report Date
    February 20, 2009
    Manufacturer
    BD DIAGNOSTICS
    Product Code
    MDB
    PMA / PMN Number
    K974883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO RETURNS WERE RECEIVED FOR TESTING FROM THE CUSTOMER. DUE TO THE NATURE OF THE ORGANISM THAT IS BEING IDENTIFIED, THE PACKAGE INSERT CONTAINS THE FOLLOWING PRECAUTIONS: "WORKING WITH MYCOBACTERIUM TUBERCULOSIS GROWN IN CULTURE REQUIRES BIOSAFETY LEVEL 3 PRACTICES, CONTAINMENT EQUIPMENT AND FACILITIES. IN THE EVENT OF TUBE BREAKAGE: CLOSE THE INSTRUMENT DRAWERS; TURN OFF THE INSTRUMENT; VACATE THE AREA IMMEDIATELY; CONSULT YOUR FACILITY/CDC GUIDELINES. AN INOCULATED LEAKING OR BROKEN VIAL MAY PRODUCE AN AEROSOL OF MYCOBACTERIA; APPROPRIATE HANDLING SHOULD BE OBSERVED." ROOT CAUSE OF THIS ISSUE WAS FAILURE BY THE CUSTOMER TO SEAT THE TUBES COMPLETELY BEFORE CLOSING THE DRAWER. A TREND ANALYSIS WAS PERFORMED FOR THIS BATCH NUMBER AND NO OTHER COMPLAINTS WERE NOTED. BD WILL CONTINUE TO MONITOR THIS TYPE OF ISSUE.

    Description of Event or Problem · 1

    CUSTOMER WAS RUNNING A ANTIMICROBIAL SUSCEPTABILITY TEST (AST) ON MYCOBACTERIUM TUBERCULOSIS USING THE BACTEC MGIT MYCOBACTERIA GROWTH INDICATOR TUBE 7ML IN THE BACTEC MGIT 960 INSTRUMENT. THE CUSTOMER DID NOT FULLY SEAT THE CARRIER SET AND WHEN THE CUSTOMER CLOSED THE DRAWER, THE TUBE WAS BROKEN. THE TECH WAS NOT WEARING A MASK OR GOWN. UPON HEARING THE TUBE BREAK, THE TECH EXITED THE ROOM IMMEDIATELY. THE BROKEN TUBE CONTAINED A SUSPENSION OF MYCOBACTERIUM TUBERCULOSIS ATCC 27294. AFTER PUTTING ON PERSONAL PROTECTION EQUIPMENT (PPE), SHE REENTERED THE ROOM AND DISCARDED ALL THE TUBES IN THE DRAWER WHERE THE BREAKAGE OCCURRED. TUBES IN THE REMAINDER OF THE INSTRUMENT WERE MOVED TO ANOTHER INSTRUMENT AND THE ORIGINAL INSTRUMENT TURNED OFF. THE TECH IS CURRENTLY BEING EVALUATED BY THE IN HOUSE (B)(6) FOR EXPOSURE. SHE RECEIVED A (B)(6) AND WILL RETURN IN THREE MONTHS FOR ANOTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BBL MGIT MYCOBACTERIA GROWTH INDICATOR TUBE 83MDB MDB BD DIAGNOSTICS 8239756

    Patients

    Seq Age Sex Outcome Treatment
    1 Other