BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA

    MDR report key: 25230072 · Received May 20, 2026

    Report

    Report Number
    1710034-2026-00540
    Event Type
    Malfunction
    Date Received
    May 20, 2026
    Date of Event
    May 4, 2026
    Report Date
    May 8, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835195
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G.4. K183399; K243403 H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IV LEAKED AT THE SEPTUM. (B)(6) 2026 - AFTER SUCCESSFUL PLACEMENT, THE IV SYSTEM LEAKED OUT THE PORTAL OF ENTRY AFTER THE NEEDLE WAS REMOVED. A NEW IV NEEDED TO BE PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37640 NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5329063 00382903835195

    Patients

    Seq Age Sex Outcome Treatment
    1