BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA

    MDR report key: 22947895 · Received September 2, 2025

    Report

    Report Number
    1710034-2025-01441
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    July 28, 2025
    Report Date
    October 3, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835102
    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

    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

    COMPLAINT CATEGORY: DAMAGED / BROKEN INCIDENT DATE: 28 JUL 2025 DETAILS OF COMPLAINT (REPORTED ISSUE): ¿WRITER WENT TO ASSESS PIV; PIV APPEARED TO BE FLUSHING WELL. ON ASSESSMENT, WRITER NOTICED THAT FLUSH VOLUME HAD ABSORBED INTO PIV ARM BOARD AS PIV ARM BOARD WAS MOIST. ON ASSESSMENT, THE PIV CATHETER TUBING WAS NOTED TO BE SNAPPED IN HALF.¿ COMPLAINT NOTICED: DURING / AFTER USE. PROBLEM FREQUENCY: 1ST TIME. PATIENT INJURY: NO.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1809617 NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 00382903835102

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown