BEUDAMED
    FDA Adverse Event Other Summary report: N

    BBL MGIT MYCOBACTERIA GROWTH INDICATOR TUBE

    MDR report key: 1001480 · Received February 20, 2008

    Report

    Report Number
    1119779-2008-00003
    Event Type
    Other
    Date Received
    February 20, 2008
    Date of Event
    November 26, 2007
    Report Date
    February 19, 2008
    Manufacturer
    BD DIAGNOSTICS
    Product Code
    MDB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    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. ALTHOUGH THE CUSTOMER REPORTED THE TUBES WERE DAMAGED DURING TRANSPORT, ADD'L LOTS OF RETENTION SAMPLES WERE EXAMINED AND A LOW LEVEL OF CRACKED TUBES WERE OBSERVED. ROOT CAUSE HAS BEEN DETERMINED TO BE A COMBINATION OF THE STRESS OF MFG EQUIPMENT, AND THE FRAGILITY OF THE PLASTIC TUBE. IMMEDIATE CORRECTIVE ACTION IMPLEMENTED TO HAVE 100% MANUAL INSPECTION OF ALL TUBES UNTIL AN AUTOMATED SOLUTION CAN BE IMPLEMENTED. A WORLDWIDE SAFETY ALERT WAS ISSUED JANUARY 2008 TO REENFORCE THE SAFETY PRECAUTIONS FOR USING THIS PROD.

    Description of Event or Problem · 1

    BD DIAGNOSTIC SYS IN SPARKS, MD REC'D THE FOLLOWING COMPLAINT IN EARLY 2008. IN 2007, A CULTURE WAS ENTERED INTO THE BACTEC MGIT 960 INSTRUMENT AT A SWEDISH CUSTOMER SITE. THE INSTRUMENT INDICATED A POSITIVE TUBE ON SIX DAYS LATER AND WHEN THEY REMOVED THE TUBE, THE VOLUME WAS LESS THAN THE 7ML AND THE TUBE SHOWED A VISIBLE CRACK. THE TUBE WAS INOCULATED WITH A KNOWN STRAIN OF MYCOBACTERIA TUBERCULOSIS AS PART OF A PANEL SENT OUT BY THE SWEDISH INSTITUTE OF INFECTIOUS DISEASE CONTROL. THE STRAIN HAS A NORMAL SUSCEPTIBILITY PATTERN. THE LAB WAS IMMEDIATELY EVACUATED AND THE INSTRUMENT TURNED OFF. THE INSTRUMENT WAS DECONTAMINATED AND LABORATORY PERSONNEL ARE BEING TESTED WITH PPD AND X-RAY. THE CUSTOMER INDICATED THAT THE TUBES USED IN THE INSTRUMENT WERE DAMAGED DURING TRANSPORT. BD PERSONNEL COUNSELLED THE LAB TO NEVER USE DAMAGED TUBES AND ALWAYS INSPECT THEM PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BBL MGIT MYCOBACTERIA GROWTH INDICATOR TUBE 83MDB MDB BD DIAGNOSTICS 7162421

    Patients

    Seq Age Sex Outcome Treatment
    1