BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-TIP

    MDR report key: 22860691 · Received August 21, 2025

    Report

    Report Number
    22860691
    Event Type
    Malfunction
    Date Received
    August 21, 2025
    Date of Event
    June 3, 2025
    Report Date
    June 30, 2025
    Manufacturer
    NATIONAL MEDICAL PRODUCTS, INC.
    Product Code
    KZE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RN FILLED J-TIP WITH LIDOCAINE PRIOR TO PIV [PERIPHERAL INTRAVENOUS LINE] INSERTION. SAFETY REMOVED AND RN ATTEMPTED TO PUSH LEVEL TO ENGAGE J-TIP. J-TIP NEVER ENGAGED/TRIGGERED. THE LEVER WAS PUSHED ALL THE WAY IN TO BE ENGAGED AND MEDICATION NEVER DISCHARGED. RN HAD TO PULL UP MORE MEDICATION INTO NEW J-TIP. THIS DELAYED PATIENT CARE. LOT #: 2406001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2203852 J-TIP INJECTOR, FLUID, NON-ELECTRICALLY POWERED KZE NATIONAL MEDICAL PRODUCTS, INC. 8164200125 2406001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown