BEUDAMED
    FDA Adverse Event Other Summary report: N

    BBL MIGIT MYCROBACTERIA GROWTH INDICATOR TUBE

    MDR report key: 983757 · Received January 18, 2008

    Report

    Report Number
    1119779-2008-00001
    Event Type
    Other
    Date Received
    January 18, 2008
    Date of Event
    December 20, 2007
    Report Date
    January 18, 2008
    Manufacturer
    BD DIAGNOSTICS
    Product Code
    MDB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO RETURNS WERE REC'D 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. 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 MYCOBACTERIA; APPROPRIATE HANDLING SHOULD BE OBSERVED." RETENTION SAMPLES OF THE INDICATED LOT WERE REVIEWED AND SHOW NO EVIDENCE OF CRACKING. ADD'L LOTS OF RETENTION SAMPLES WERE EXAMINED AND A LOW LEVEL OF CRACKED TUBES WERE OBSERVED. ROOT CAUSE INVESTIGATION IS ONGOING. TO DATE, ALL INCOMING MATERIALS WERE REINSPECTED TO SHOW NO DEFECTS. THE ROOT CAUSE INVESTIGATION WILL CONTINUE FOCUSING ON PRODUCTION EQUIPMENT.

    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. RIGHT AFTER THEY PLACED THE CARRIER INTO THE INSTRUMENT, THE CUSTOMER NOTICED A SMALL POND OF LIQUID UNDER THE AST SET CARRIER. WHEN THE CARRIER WAS REMOVED, THE NOTICED A PORTION OF THE LIQUID WAS MISSING FROM THE STREPTOMYCIN TUBE. THE TUBE APPEARED HALF FULL AND WAS WET ON THE OUTSIDE. THE TUBE SHOWED VISIBLE CRACKS. THE MGIT INSTRUMENT IS NOT IN THE MAIN TB ROOM USED FOR PROCESSING SPECIMENS BUT IN AN ANTEROOM. WHEN THE AST CARRIER WAS REMOVED, THE CUSTOMER WAS WEARING GLOVES AND A LABCOAT BUT NO RESPIRATOR. CUSTOMER IMMEDIATELY EVACUATED THE ROOM AND DECONTAMINATED THE ROOM/INSTRUMENT LATER. REPEAT TESTING DETERMINED THAT THE ORGANISM WAS FULLY SUSCEPTIBLE. CUSTOMER EXAMINED THEIR INVENTORY AND FOUND ADD'L TUBES WITH LEAKS AND CRACKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BBL MIGIT MYCROBACTERIA GROWTH INDICATOR TUBE 83MDB MDB BD DIAGNOSTICS 7198363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other