BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOJECTOR

    MDR report key: 571873 · Received February 3, 2005

    Report

    Report Number
    MW1034592
    Event Type
    Malfunction
    Date Received
    February 3, 2005
    Date of Event
    December 14, 2004
    Report Date
    February 1, 2005
    Manufacturer
    BIOJECT, INC.
    Product Code
    KZE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A SUBJECT VISIT FOR CLINICAL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF THE HIV-1 DNA VACCINE THERE WAS AN INADVERTENT ACTIVATION OF THE BIOJECTOR WITH INJECTION OF THE STUDY PRODUCT INTO THE BIOJECTOR CAP. A THREE INCH MIST WAS OBSERVED AROUND THE CAP. NEITHER THE SUBJECT NOR SITE PERSONNEL WERE DIRECTLY EXPOSED TO THE STUDY VACCINE. THE EVENT WAS DEEMED UNRELATED TO THE STUDY BY SITE PERSONNEL. THIS REPORT IS BEING SUBMITTED AT THE REQUEST OF THE MEDICAL OFFICER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOJECTOR INJECTION DEVICE KZE BIOJECT, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other