BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE

    MDR report key: 6770398 · Received August 7, 2017

    Report

    Report Number
    6770398
    Event Type
    Malfunction
    Date Received
    August 7, 2017
    Date of Event
    June 29, 2017
    Report Date
    July 28, 2017
    Manufacturer
    GREINER BIO-ONE NORTH AMERICA, INC.
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RN IN HALLWAY WALKING TOWARDS BLUE POD TUBE SYSTEM CARRYING A GOLD TOP TUBE OF BLOOD. RN HAD GLOVES ON AND WAS GENTLY ROTATING VIAL BACK AND FORTH WHILE WALKING. SHE STATED SUDDENLY THE "TOP OF THE TUBE POPPED OFF LIKE THE CORK OF A CHAMPAGNE BOTTLE." BLOOD SPLATTERED ONTO RN'S FACE INCLUDING LIP (BUT NOT IN EYES OR MOUTH) ON NECK, SHIRT AND RIGHT ARM. BLOOD ALSO SPRAYED ON FLOOR. RN IMMEDIATELY WASHED ALL SPLATTERED AREAS OF BODY WITH SOAP AND WATER. REFERRED TO HOSPITAL POLICY REGARDING EMPLOYEE EXPOSURE TO BLOOD-BORNE PATHOGENS AND SENT RN TO EMPLOYEE HEALTH IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550862 VACUETTE TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA GREINER BIO-ONE NORTH AMERICA, INC. B17043E5

    Patients

    Seq Age Sex Outcome Treatment
    1