BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA MAXZERO

    MDR report key: 22806862 · Received August 14, 2025

    Report

    Report Number
    1710034-2025-01343
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    August 5, 2025
    Report Date
    September 15, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835560
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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

    IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY, A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 5120882. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ONE PHOTOGRAPH OF A NEXIVA UNIT PACKAGE WAS PROVIDED FOR EVALUATION. THE IMAGE SHOWED THAT THE TOP WEB WAS NOT SEALED TO THE BOTTOM WEB, LIKELY DUE TO THE PRESENCE OF BLACK SPLICE TAPE ACROSS THE SEALING AREA. SPLICE TAPE IS USED DURING THE PACKAGING PROCESS TO SPLICE NEW ROLLS OF TOP WEB AND CHALLENGE THE VISION SYSTEM. IT IS THE OPERATOR¿S RESPONSIBILITY TO ENSURE THAT TAPED UNITS ARE REJECTED AND DO NOT PROCEED THROUGH THE PACKAGING LINE. BASED ON THE RESULTS OF THIS INVESTIGATION, THE REPORTED COMPLAINT WAS CONFIRMED AND DETERMINED TO BE RELATED TO OPERATOR ERROR DURING MANUFACTURING. TO PREVENT FUTURE OCCURRENCES OF THIS EVENT OUR ENGINEERS HAVE ISSUED A NOTIFICATION TO THE APPROPRIATE PERSONNEL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA MAXZERO OPEN PACKAGE SEAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PRODUCT WAS OPENED/EXPOSED WITH A BLACK STRIP OF TAPE.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865894 NEXIVA MAXZERO PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5120882 00382903835560

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown