BEUDAMED
    FDA Adverse Event Summary report: N

    BIOJECTOR 2000

    MDR report key: 764905 · Received August 10, 2006

    Report

    Report Number
    764905
    Date Received
    August 10, 2006
    Date of Event
    August 2, 2006
    Report Date
    August 10, 2006
    Manufacturer
    BIOJECT MEDICAL TECHNOLOGIES, INC.
    Product Code
    KZE
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    A PHASE I CLINICAL TRIAL TO EVALUATE IMMUNE RESPONSE KINETICS AND SAFETY OF TWO DIFFERENT PRIMES: ADENOVIRAL VECTOR VACCINE AND DNA VACCINE; EACH FOLLOWED BY ADENOVIRAL BOOST IN HEALTHY, HIV-1 UNINFECTED ADULTS. THIS VACCINE IS GIVEN VIA IM INJECTION TO A NORMAL VOLUNTEER'S DELTOID USING A NEEDLE-FREE INJECTION SYSTEM PRODUCED BY BIOJECTOR. DURING A ROUTINE INJECTION AND AT THE TIME THE TRIGGER WAS PULLED, THE BIOJECTOR "KICKED-BACK" BREAKING THE SEAL BETWEEN THE ARM AND THE SYRINGE. RESULT: 1. AN INCOMPLETE INJECTION WAS GIVEN. SOME VACCINE ENTERED THE VOLUNTEER AND SOME VACCINE APPEARED ON THE SURFACE OF THE ARM (USING GAUZE SPONGE VACCINE WAS COLLECTED AND PLACED IN A YELLOW BIOHAZARD BAG).2. AT THE INJECTION SITE, A ONE CENTIMETER LONG, SUPERFICIAL LACERATION RESULTED FROM THE EXTERNAL STREAM OF VACCINE (AN OVAL DOT BANDAGE WAS APPLIED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOJECTOR 2000 INJECTION SYSTEM, NEEDLELESS KZE BIOJECT MEDICAL TECHNOLOGIES, INC. BIOJECTOR 2000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *