BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CANNON II PLUS REPLACEMENT HUB SET

    MDR report key: 25068743 · Received May 4, 2026

    Report

    Report Number
    9680794-2026-00329
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    April 2, 2026
    Report Date
    April 8, 2026
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    NFK
    UDI-DI
    20801902195238
    PMA / PMN Number
    K020430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "ON (B)(6) 2026, THE EXTENSION LINE WAS FOUND LEAKING DURING USED ON THE PATIENT." THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THE EVENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE. NO MEDICAL INTERVENTION WAS NECESSARY, AND THE PROCEDURE WAS COMPLETED AFTER SWITCHING TO AN ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54089 ARROW CANNON II PLUS REPLACEMENT HUB SET KIT, REPAIR, CATHETER, HEMODI NFK ARROW INTERNATIONAL LLC 33F24H0046 20801902195238

    Patients

    Seq Age Sex Outcome Treatment
    1