BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA 18 GA X 1.25IN SP WITH MAXZERO

    MDR report key: 23542249 · Received November 13, 2025

    Report

    Report Number
    9610847-2025-00423
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Date of Event
    October 28, 2025
    Report Date
    November 24, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903835591
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 383559 AND LOT NUMBER 5150492. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE, AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Description of Event or Problem · 0

    MATERIAL # 383577. IT WAS REPORTED BY CUSTOMER THAT THERE IS BACKFLOW OF BLOOD OUT OF THE END OF THE CLOSED CATHETER SYSTEM WHEN IT SHOULD BE CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2249758 NEXIVA 18 GA X 1.25IN SP WITH MAXZERO INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 5150492 00382903835591

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown