BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIERPRO LANCET

    MDR report key: 23200074 · Received October 2, 2025

    Report

    Report Number
    23200074
    Event Type
    Malfunction
    Date Received
    October 2, 2025
    Date of Event
    September 17, 2025
    Report Date
    September 17, 2025
    Manufacturer
    SVS LLC
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    LUER LOCK ACCESS DEVICE BROKE OFF ON THE IV THAT WAS PLACED IN PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313099 PREMIERPRO LANCET NEEDLE, HYPODERMIC, SINGLE LUMEN FMI SVS LLC 7580 CDKL 10-02

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown