BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA

    MDR report key: 24631467 · Received March 18, 2026

    Report

    Report Number
    1710034-2026-00293
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    March 6, 2026
    Report Date
    March 13, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835126
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G.4 K183399; K243403.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER REPORT, MEDICINE SOLUTION WAS LEAKING FROM THE NEXIVA CATHETER. AFTER NEXIVA IMPLANTATION, THE PATIENT OBSERVED REVERSE BLOOD LEAKAGE FROM THE CATHETER PORTION, AND WHEN THE CATHETER WAS REMOVED, DAMAGE WAS OBSERVED (NOT VISIBLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688174 NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 00382903835126

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown