BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAC T/ALERT BLOOD COLLECTION ADAPTER

    MDR report key: 503178 · Received December 18, 2003

    Report

    Report Number
    1039284-2003-00013
    Event Type
    Injury
    Date Received
    December 18, 2003
    Date of Event
    November 13, 2003
    Report Date
    December 18, 2003
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    MDB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A NURSE WAS DRAWING BLOOD INTO A VACCUM THE TUBE USING THE BACT/ALERT ADAPTER CAP AND INSERT. THE STOPPER IN THE TEST TUBE CAME OUT WHEN THEY WERE WITHDRAWING THE TUBE FROM THE ADATPER CAP AND INSERT. BLOOD SPLASHED IN THE NURSE'S FACE AND MOUTH. THE NURSE WAS GIVEN A TETANUS AND HEPATITIS B BOOSTER SHOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAC T/ALERT BLOOD COLLECTION ADAPTER 21CFR 862. 1675 BLOOD SPECIMEN COLLECTION DEVICE MDB BIOMERIEUX, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention