BEUDAMED
    FDA Adverse Event Summary report: N

    J-TIP

    MDR report key: 3426889 · Received June 7, 2013

    Report

    Report Number
    3426889
    Date Received
    June 7, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 7, 2013
    Manufacturer
    NATIONAL MEDICAL PRODUCTS, INC.
    Product Code
    KZE
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    J-TIP "EXPLODED" WHILE BEING ADMINISTERED PRIOR TO PERIPHERAL IV PLACEMENT. PART OF THE J-TIP CLOSEST TO END SHATTERED INTO SMALL PIECES. MEDICATION DID NOT WORK AS INTENDED. DEFECTIVE J-TIP GIVEN TO ED PHARMACIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254252 J-TIP INJECTOR, FLUID KZE NATIONAL MEDICAL PRODUCTS, INC. 0.25 ML 130516-23831

    Patients

    Seq Age Sex Outcome Treatment
    1 *