BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIC ANTI STICK NEEDLE

    MDR report key: 23479227 · Received November 5, 2025

    Report

    Report Number
    MW5178546
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 29, 2025
    Report Date
    October 31, 2025
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NEWLY OPENED MEDIC ANTI STICK NEEDLE/CONNECTOR FOUND TO HAVE BLACK SPOTS/DEBRIS IN IT. DID NOT IMPACT A PATIENT AS IT WAS CAUGHT BEFORE USE. THIS IS THE SECOND SIMILAR REPORT IN 24 HOURS REGARDING THIS DEVICE. 1ST PRODUCT IDENTIFIER REF M85007, 2 OCCURRENCE LOT NUMBER 41180011. MANUFACTURER TO BE NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2280890 MEDIC ANTI STICK NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI NXSTAGE MEDICAL, INC. 41180011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other