BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMEDIX

    MDR report key: 22297698 · Received June 20, 2025

    Report

    Report Number
    3003674698-2025-00982
    Event Type
    Malfunction
    Date Received
    June 20, 2025
    Date of Event
    May 16, 2025
    Report Date
    June 20, 2025
    Manufacturer
    MEDSOURCE LABS LLC
    Product Code
    LHI
    UDI-DI
    00851470007057
    PMA / PMN Number
    K142097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE USER IS EXPERIENCING RESISTANCE WHEN ATTEMPTING TO PUSH FLUID THROUGH THE INJECTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2102232 BIOMEDIX B31 SELEC-3 NIS LAS IV ADM SET LHI MEDSOURCE LABS LLC B31-102 B40711 AND B40959 00851470007057

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other