BEUDAMED
    FDA Adverse Event Other Summary report: N

    COOL CLICK NOZZLE

    MDR report key: 390237 · Received April 23, 2002

    Report

    Report Number
    3023012-2002-00001
    Event Type
    Other
    Date Received
    April 23, 2002
    Date of Event
    March 11, 2002
    Report Date
    April 19, 2002
    Manufacturer
    BIOJECT, INC.
    Product Code
    KZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COOL CLICK DEVICE WAS USED TO DELIVER SALINE INJECTIONS TO FIVE TEST SUBJECTS AS PART OF A DEMONSTRATION OF NEEDLE-FREE DRUG DELIVERY. ONE DISPOSABLE NOZZLE WAS USED ON ALL FIVE SUBJECTS, CONTRARY TO THE PRODUCT'S INSTRUCTIONS FOR USE PAMPHLET, BIOJECT'S TRAINING VIDEO, AND LABELING ON THE NOTICE CARD IN EACH BOX OF NOZZLES AND ON THE NOZZLE PACKAGE LABEL. REUSE OF THE NOZZLE EXPOSED SUBSEQUENT SUBJECTS TO THE BLOOD AND/OR BODY FLUIDS OF THE PREVIOUS SUBJECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL CLICK NOZZLE NEEDLE-FREE DELIVERY SYSTEM KZE BIOJECT, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention