BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-TIP NEEDLE FREE INJECTOR

    MDR report key: 2664360 · Received July 16, 2012

    Report

    Report Number
    MW5026203
    Event Type
    Malfunction
    Date Received
    July 16, 2012
    Date of Event
    July 9, 2012
    Report Date
    July 16, 2012
    Manufacturer
    NATIONAL MEDICAL PRODUCTS INC.
    Product Code
    KZE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THERE HAVE BEEN SEVERAL EVENTS IN WHICH THE J-TIP APPLICATORS BREAK AT POINT OF ADMINISTRATION. THIS HAS RESULTED IN SEVERAL NEAR MISS EVENTS IN WHICH RN ADMINISTRATING THE MEDICATION AND THE PT TO WHICH MEDICATION WAS BEING ADMINISTERED WERE AT RISK FOR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J-TIP NEEDLE FREE INJECTOR J-TIP NEEDLE FREE INJECTOR KZE NATIONAL MEDICAL PRODUCTS INC. 1203001

    Patients

    Seq Age Sex Outcome Treatment
    1