BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM

    MDR report key: 24977025 · Received April 24, 2026

    Report

    Report Number
    3006425876-2026-00459
    Event Type
    Malfunction
    Date Received
    April 24, 2026
    Date of Event
    March 31, 2026
    Report Date
    March 31, 2026
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    PPO
    UDI-DI
    10801902190366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "SWG UNRAVELED. THE PATIENT WAS REPORTED AS FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489140 ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM CATHETER SUBCLAVIAN PPO ARROW INTERNATIONAL LLC 71F24H1398 10801902190366

    Patients

    Seq Age Sex Outcome Treatment
    1