BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BACT/ALERT® SA (PLASTIC BOTTLES)

    MDR report key: 6802094 · Received August 17, 2017

    Report

    Report Number
    3002769706-2017-00249
    Event Type
    Injury
    Date Received
    August 17, 2017
    Report Date
    September 12, 2017
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    MDB
    UDI-DI
    03573026055806
    PMA / PMN Number
    K020931
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX WAS INITIALLY INFORMED THAT BACT/ALERT® SA CULTURE BOTTLES WERE LEAKING POST SAMPLE COLLECTION. PER THE CUSTOMER, THE BOTTLES WERE LEAKING FROM THE CAP IN THE SAMPLE BAG. THE CUSTOMER STATED THE SAMPLES HAD NOT LEAKED OUTSIDE OF THE BAG; THEREFORE, STAFF MEMBERS WERE NOT AFFECTED. HOWEVER, NEW SAMPLE SETS WERE REQUIRED DUE TO THE LEAKING CULTURE BOTTLES. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER ON 24AUG2017. THE CUSTOMER REPORTED THE ISSUE WAS ALL USER ERROR. THE USER ATTEMPTED TO TAKE THE METAL CAP OFF THE BOTTLE BUT ENCOUNTERED DIFFICULTY SO STOPPED HALF WAY THROUGH. THE CUSTOMER INDICATED THE USER WAS LOOKING FOR A NEW WAY TO INOCULATE BLOOD CULTURES. THE LEAK WAS AROUND THE METAL CRIMPING WHERE THE USER HAD TAMPERED AND CAUSED DAMAGE,

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF BACT/ALERT® SA CULTURE BOTTLES LEAKING POST SAMPLE COLLECTION. PER THE CUSTOMER, THE BOTTLES WERE LEAKING FROM THE CAP IN THE SAMPLE BAG. CUSTOMER STATES THE SAMPLES HAD NOT LEAKED OUTSIDE THE BAG; THEREFORE, NO STAFF MEMBERS WERE AFFECTED. THE LEAKING BACT/ALERT® CULTURE BOTTLES INITIATED MEDICAL INTERVENTION IN THE FORM OF ADDITIONAL PATIENT BLOOD DRAWS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581264 BACT/ALERT® SA (PLASTIC BOTTLES) BACT/ALERT® SA (PLASTIC BOTTLES) MDB BIOMERIEUX, INC 259789 1047291 03573026055806

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention