BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA MAXZERO

    MDR report key: 25191209 · Received May 15, 2026

    Report

    Report Number
    1710034-2026-00525
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    April 29, 2026
    Report Date
    May 26, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835560
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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 NEXIVA LEAKED AT THE SEPTUM. IT WAS BROUGHT TO OUR ATTENTION THIS MORNING THAT ONE OF THE 20G NEXIVA CATH IV WAS LEAKING FROM THE ACCESS PORT WHEN CONNECTED TO A PATIENT. WE PULLED THE AFFECTED LOT FROM THE FLOOR AND STOREROOM. PLEASE ADVISE FURTHER INSTRUCTIONS OR ACTIONS TO BE TAKEN. ADDITIONAL INFORMATION 5/5/2026: WHAT WAS THE IMPACT TO THE PATIENT OR HCP? THE PATIENT HAD TO RE-POKED X2 TO ESTABLISH NEW ACCESS ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429663 NEXIVA MAXZERO PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6056783 00382903835560

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown