BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BBL MGIT MYCOBACTERIA GROWTH INDICATOR TUBE

    MDR report key: 2494166 · Received March 13, 2012

    Report

    Report Number
    1119779-2012-00002
    Event Type
    Injury
    Date Received
    March 13, 2012
    Date of Event
    February 13, 2012
    Report Date
    February 13, 2012
    Manufacturer
    BD DIAGNOSTIC SYSTEMS
    Product Code
    MDB
    PMA / PMN Number
    K974883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNS WERE NOT AVAILABLE FROM THE CUSTOMER FOR FURTHER EVAL. RETENTION SAMPLES WERE EXAMINED AND NO CRACKS WERE EVIDENT. BATCH HISTORY RECORD WAS REVIEWED WITH SATISFACTORY RESULTS. THE BROKEN TUBE IS A RESULT OF THE TUBE NOT BEING FULLY SEATED AS THE SAMPLES WERE LOADED INTO THE MGIT 960 INSTRUMENT. SINCE THE LAB WORKER WAS INOCULATING THE SUSCEPTIBILITY TEST WITH A STRAIN OF MYCOBACTERIUM TUBERCULOSIS WHEN THE DRAWER WAS CLOSED AND THE TUBE WAS BROKEN, THERE IS A RISK OF A POTENTIAL AEROSOL EXPOSURE WHEN THE TOP OF THE TUBE WAS BROKEN. USERS ARE INSTRUCTED TO ¿MAKE SURE THAT ALL THE TUBES AND THE CARRIERS ARE FULLY SEATED IN THE DRAWER¿ PER THE BACTEC MGIT USER¿S MANUAL. AT THIS TIME NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS PRODUCT LOT; THEREFORE, THIS IS CONSIDERED AN ISOLATED INCIDENT. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BD WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TECHNOLOGIST DID NOT PUSH THE TUBE IN THE AST SET CARRIER ALL THE WAY DOWN. WHEN THE DRAWER WAS CLOSED, THE MGIT TUBE CRACKED AT THE TOP. THE TECHNOLOGIST WAS WEARING A LAB COAT AND GLOVES BUT NO RESPIRATORY PROTECTION. THE CUSTOMER TURNED THE INSTRUMENT OFF AND PUT TUBERCULOCIDAL SOLUTION IN THE AFFECTED DRAWER. AN INCIDENT REPORT WAS FILED. THIS TUBE WAS AN INOCULATED AST SET THEREFORE IT DID CONTAIN LIVE (B)(6) CULTURE. THE CUSTOMER DID NOT KNOW WHICH TUBE WAS BROKEN (GROWTH CONTROL OR DRUG VIAL). IT IS NOT KNOWN IF THE (B)(6) STRAIN WAS SENSITIVE OR A MULTIDRUG RESISTANT STRAIN. DURING A F/U CALL WITH THE CUSTOMER THEY STATED THAT THE TECHNOLOGIST WAS FINE BUT INDICATED HE WAS UNABLE TO DISCLOSE ANY FURTHER INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BBL MGIT MYCOBACTERIA GROWTH INDICATOR TUBE MDB BD DIAGNOSTIC SYSTEMS 1245796

    Patients

    Seq Age Sex Outcome Treatment
    1 Other