BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    #2 SYRINGE

    MDR report key: 208027 · Received January 28, 1999

    Report

    Report Number
    3023012-1999-00001
    Event Type
    Malfunction
    Date Received
    January 28, 1999
    Date of Event
    December 22, 1998
    Report Date
    January 28, 1999
    Manufacturer
    BIOJECT INC.
    Product Code
    KZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE GIVING AN INJECTION WITH A BIOJECT NEEDLE FREE JET INJECTOR, THE SYRINGE CRACKED AND SOME MEDICATION (VACCINE) SQUIRTED INTO THE FACE OF THE NURSE GIVING THE INJECTION. FOLLOWING THE INCIDENT THE NURSE RINSED HER FACE AND EYES. THERE WERE NO INJURIES TO EITHER THE PT OR THE NURSE. NO TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 #2 SYRINGE NEEDLE-FREE SYRINGE KZE BIOJECT INC. #2 SYRINGE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA BIOJECTOR 2000 INJECTOR.