BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-TIP

    MDR report key: 8686578 · Received June 11, 2019

    Report

    Report Number
    8686578
    Event Type
    Malfunction
    Date Received
    June 11, 2019
    Date of Event
    March 5, 2019
    Report Date
    April 1, 2019
    Manufacturer
    NATIONAL MEDICAL PRODUCTS, INC.
    Product Code
    KZE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LIDOCAINE 1% BUFFERED 1% INJECTION (J-TIP) WAS USED ON A PATIENT FOR A PERIPHERAL IV START. UPON ACTIVATION OF THE DEVICE TO ADMINISTER THE DRUG THE SYRINGE CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482956 J-TIP INJECTOR, FLUID, NON-ELECTRICALLY POWERED KZE NATIONAL MEDICAL PRODUCTS, INC. 190224-040

    Patients

    Seq Age Sex Outcome Treatment
    1 4015 DA