BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM

    MDR report key: 24814136 · Received April 8, 2026

    Report

    Report Number
    9680794-2026-00276
    Event Type
    Malfunction
    Date Received
    April 8, 2026
    Date of Event
    March 9, 2026
    Report Date
    March 17, 2026
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    PPO
    UDI-DI
    20801902096610
    PMA / PMN Number
    K111117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER REPORT THAT "THE HUB CONNECTION SEPARATED FROM THE ASSEMBLY" COULD NOT BE CONFIRMED. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED, AND A RESPONSE WAS RECEIVED. THE HUB ASSEMBLY FELL ON THE FLOOR. NO HARM CAME TO THE PATIENT, AND ANOTHER KIT WAS OPENED. WITHOUT THE DEVICE TO EVALUATE, THE COMPLAINT COULD NOT BE CONFIRMED, AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "THE HUB CONNECTION SEPARATED FROM THE ASSEMBLY WHEN DR. W. WAS ATTEMPTING TO PLACE THE CATHETER. THE HUB ASSEMBLY FELL ON THE FLOOR, SO WE HAD TO OPEN ANOTHER CATHETER KIT. THE WAS NOT ON THE PATIENT YET. IT WAS AFTER OPENING THE KIT. THE PACKAGING WAS NOT DAMAGED. NO HARM CAME TO THE PATIENT. WE HAD TO OPEN ANOTHER CATHETER KIT. THE PATIENT IS STABLE AND HAS BEEN COMING TO DIALYSIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878040 ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM CATHETER HEMODIALYSIS IMPLANTE PPO ARROW INTERNATIONAL LLC 33F25C0688 20801902096610

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED.