BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BBL MGIT MYCOBACTERIA GROWTH INDICATOR TUBE

    MDR report key: 2212910 · Received August 10, 2011

    Report

    Report Number
    1119779-2011-00004
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    BD DIAGNOSTIC SYSTEMS
    Product Code
    MDB
    PMA / PMN Number
    K974883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 (B)(6) GROWN IN CULTURE REQUIRES BIOSAFETY LEVEL 3 PRACTICES, CONTAINMENT EQUIPMENT AND FACILITIES. PRIOR TO USE, EACH MGIT TUBE SHOULD BE EXAMINED FOR EVIDENCE OF CONTAMINATION OR DAMAGE. DISCARD ANY TUBES IF THEY APPEAR UNSUITABLE. DROPPED TUBES SHOULD BE EXAMINED CAREFULLY. IF DAMAGE IS SEEN, THE TUBE SHOULD BE DISCARDED. 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 (B)(6); APPROPRIATE HANDLING SHOULD BE OBSERVED." QUALITY WAS UNABLE TO CONDUCT FURTHER INVESTIGATION SINCE THE LOT NUMBER IS UNK. NO TRENDS WERE NOTED DURING A TREND ANALYSIS FOR THIS TYPE OF ISSUE. NO CORRECTIVE ACTIONS ARE WARRANTED AT THIS TIME AND BD WILL CONTINUE TO MONITOR THIS TYPE OF ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER WAS CONDUCTING A SUSCEPTIBILITY TEST ON A PT STRAIN OF (B)(6). THE TECHNICIAN NOTICED AFTER 2 WEEKS, THAT THE GROWTH CONTROL TUBE WAS BROKEN AND ABOUT 7MLS OF MEDIA HAVE LEAKED OUT INTO THE INSTRUMENT. THE TECH WAS WEARING GLOVES AND A LABCOAT. THE HOSPITAL SAFETY OFFICER WAS CONTACTED AND IS WORKING WITH THE LAB. THE TECHS ARE NOW WEARING RESPIRATORS AT ALL TIMES AND HAVE HAD A (B)(6) THIS WEEK. A F/U TEST WILL BE CONDUCTED IN 12 WEEKS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other