BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA

    MDR report key: 25188571 · Received May 15, 2026

    Report

    Report Number
    1710034-2026-00520
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    April 29, 2026
    Report Date
    April 30, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903836475
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    IT WAS REPORTED THAT THE TUBING BROKE. 20G NEXIVA DUAL PORT INSERTED THE MORNING OF THE 29TH OF APRIL, PATIENT HAD A SHOWER AND HAD A PLASTIC SHOWER SLEEVE INSITU. WHEN SHOWER SLEEVE REMOVED, BLOOD NOTICED, NEXIVA EXTENSION SET WAS IN 2 PIECES, SLICED DIRECTLY ACROSS. UNKNOWN AS TO HOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215480 NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5155701 00382903836475

    Patients

    Seq Age Sex Outcome Treatment
    1