BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA

    MDR report key: 22967701 · Received September 4, 2025

    Report

    Report Number
    1710034-2025-01452
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    August 1, 2025
    Report Date
    September 11, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835324
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    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

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 383532 AND LOT NUMBER 5003783. 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS THAT WHEN PERFORMING THE PROCEDURE, IT IS LEAKING AT THE CONNECTOR, SO HE DISCARDS THE PART AND TAKES ANOTHER ONE TO CONTINUE. ADD INFO RECEIVED ON 19 AUG 2025 IS THERE ANY IMPACT ON THE PATIENTS? IF YES, PLEASE EXPLAIN IN DETAIL. DELAY IN PROCEDURE (20 MIN APPROX). COULD YOU PLEASE CONFIRM THE DATE THE EVENT OCCURRED (DD/MMM/YYYYYY)? 01/AUG/2025.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2081356 NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5003783 00382903835324

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown