BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYMER ANGIOLOCK LIGATION CLIP

    MDR report key: 23533144 · Received November 12, 2025

    Report

    Report Number
    MW5178756
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    November 6, 2025
    Report Date
    November 6, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP - NORTHFIELD
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DEFECTIVE HEMOLOCK GREEN CLIP X2 OUT OF 12 CLIPS OPENED IN THE FIELD. NO HARM DONE TO THE PATIENT AS THE SURGEON NOTICED THE DEFECT BEFORE IT IS USED TO THE PATIENT. SURGEON USED A DIFFERENT CLIP (LARGE PURPLE CLIP) INSTEAD. TL NOTIFIED AND DEFECTED CLIPS WERE HANDED OVER TO THE TL. DEFECTIVE CLIP NAME IS POLYMER ANGIOLOCK LIGATION CLIP (GREEN CLIP). PATIENT: 4582. DEVICE: 2588;3023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2141176 POLYMER ANGIOLOCK LIGATION CLIP CLIP, IMPLANTABLE FZP MEDLINE INDUSTRIES, LP - NORTHFIELD MDS6PML1

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female