BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA

    MDR report key: 25200888 · Received May 18, 2026

    Report

    Report Number
    1710034-2026-00529
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    April 27, 2026
    Report Date
    May 4, 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 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

    THIS IS A REPORT ABOUT BLOOD LEAKAGE. ACCORDING TO THE CUSTOMER REPORT, THE BLOOD WAS LEAKING FROM THE BASE OF THE EXTENSION TUBE DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214992 NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5261042 00382903835126

    Patients

    Seq Age Sex Outcome Treatment
    1