BEUDAMED
    FDA Adverse Event Other Summary report: N

    BBL MGIT MYCOBACTERIA GROWTH INDICATOR TUBE

    MDR report key: 1066029 · Received June 26, 2008

    Report

    Report Number
    1119779-2008-00009
    Event Type
    Other
    Date Received
    June 26, 2008
    Date of Event
    June 6, 2008
    Report Date
    June 25, 2008
    Manufacturer
    BD DIAGNOSTICS
    Product Code
    MDB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNS WERE UNAVAILABLE FOR INVESTIGATION. RETENSION SAMPLES OF THE INDICATED LOT WERE REVIEWED AND SHOW NO EVIDENCE OF CRACKS OR LOW FILL VOLUME. REVIEW OF THE MFG RECORD INDICATES THAT THIS BATCH OF MATERIAL WAS 100% VISUALLY INSPECTED PRIOR TO RELEASE WITH ZERO CRACKED TUBES NOTED. A TREND WAS IDENTIFIED IN THIS PRODUCT FAMILY FOR CRACKS. THE ROOT CAUSE WAS DETERMINED TO BE A COMBINATION OF THE STRESS OF MFG EQUIPMENT AND THE FRAGILITY OF THE PLASTIC TUBE. CORRECTIVE ACTION WAS IMPLEMENTED TO HAVE 100% MANUAL INSPECTION OF ALL TUBES UNTIL AN AUTOMATED SOLUTION CAN BE IMPLEMENTED. A WORLDWIDE SAFETY ALERT WAS ISSUED JAN 2008 TO REINFORCE THE SAFETY PRECAUTIONS FOR USING THIS PRODUCT. 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 TO BE 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." BD WILL CONTINUE TO MONITOR THIS SITUATION.

    Description of Event or Problem · 1

    A CUSTOMER CALLED TO REPORT THAT AFTER REMOVING A POSITIVE TUBE FROM THE BACTEC MGIT 960 INSTRUMENT, ONE OF THEIR STAFF NOTED A LARGE CRACK IN THE TUBE WHILE VORTEXING. THE TUBE DID NOT BREAK. THE TECH STOPPED HER PROCEDURE TO AVOID FURTHER STRESS ON THE TUBE. NO VISIBLE SIGNS OF LEAKAGE COULD BE DETECTED ON THE TUBE OR IN THE INSTRUMENT. THE LIQUID LEVEL IN THE TUBE DID NOT APPEAR NOTICEABLY LOWER. THE TECH WAS WORKING UNDER A LEVEL III HOOD AND ALL TECHS WORKING IN THIS ENVIRONMENT WEAR FULL BODY SUITS AND RESPIRATORS SINCE THE MAJORITY OF THEIR SPECIMENS ARE POSITIVE. CUSTOMER CONFIRMS THAT THE TUBES GO THROUGH AN EXTENSIVE INSPECTION FOR VISUAL CRACKS PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BBL MGIT MYCOBACTERIA GROWTH INDICATOR TUBE 82MDB MDB BD DIAGNOSTICS 7316326

    Patients

    Seq Age Sex Outcome Treatment
    1 Other