BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA MAXZERO

    MDR report key: 23015973 · Received September 10, 2025

    Report

    Report Number
    1710034-2025-01490
    Event Type
    Malfunction
    Date Received
    September 10, 2025
    Date of Event
    August 22, 2025
    Report Date
    October 16, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835522
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE COMPLAINT OF UNIDENTIFIED MATERIAL ON THE VENT PLUG WAS CONFIRMED AND THE CAUSE APPEARED TO BE MANUFACTURING RELATED. ONE 22G NEXIVA DEVICE FROM LOT #5003792 WAS PROVIDED FOR INVESTIGATION. A BROWN COLORED MATERIAL WAS EMBEDDED WITHIN THE MOLDED VENT PLUG COMPONENT, AND THE CAUSE APPEARED TO BE ASSOCIATED WITH THE MOLDING PROCESS. THE APPROPRIATE MANUFACTURING PERSONNEL WERE NOTIFIED OF THIS COMPLAINT. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.

    Description of Event or Problem · 0

    DATE OF INCIDENT: ON (B)(6) 2025 CONCERN DESCRIPTION: INSERT AN IV INTO A PATIENT AND ON VISUAL INSPECTION NOTICED BROWN/GREY MATERIAL IN THE IV PORT/TUBE. THE SUBSTANCE MAY HAVE BEEN MOLD OR DIRT, BUT IT WAS DIFFICULT TO TELL AS IT WAS INSIDE THE DEVICE. THE DEVICE WAS PREVIOUSLY SEALED. AS PER THE RN AND PSLS, THERE WAS NO PATIENT HARM, INJURY OR COMPLICATION. THIS WAS CAUGHT BEFORE IT REACHED THE PATIENT.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2500751 NEXIVA MAXZERO PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5003792 00382903835522

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown