BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOJECTOR SYRINGE

    MDR report key: 86501 · Received April 25, 1997

    Report

    Report Number
    3023012-1997-00001
    Event Type
    Malfunction
    Date Received
    April 25, 1997
    Date of Event
    March 25, 1997
    Report Date
    April 25, 1997
    Manufacturer
    BIOJECT, INC.
    Product Code
    KZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE GIVING AN INJECTION WITH THE NEEDLEFREE JET-INJECTOR, THE SYRINGE CRACKED AND SOME MEDICATION SQUIRTED OUT THE SIDE OF THE SYRINGE. A DROP OF VACCINE WAS NOTED ON THE PATIENT'S FACE. THE PATIENT WAS NOT INJURED, AND NO TREATMENT WAS REQUIRED. THE SUSPECT SYRINGE WAS EXAMINED AT OUR FACILITY, IT WAS CONFIRMED THAT THE SYRINGE HAD CRACKED. THE SYRINGE WAS OTHERSIDE FULLY INTACT. THE JET-INJECTOR DEVICE ALSO WAS EXAMINED AND FOUND TO BE FUNCTIONING WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOJECTOR SYRINGE NEEDLE-FREE SYRINGE KZE BIOJECT, INC. NO. 2 SYRINGE 50621-1

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO