BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23401778 · Received October 28, 2025

    Report

    Report Number
    9680794-2025-00874
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 2, 2025
    Report Date
    October 2, 2025
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    MSD
    UDI-DI
    00801902096289
    PMA / PMN Number
    K111117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "AFTER COMPLETION OF PROCEDURE, ON FLUSHING AND ASPIRATION OF LUMENS, LEAKAGE EXPERIENCED AT HUB ASSEMBLY, DESPITE GREEN COMPRESSION SLEEVE IN PLACE. DR REMOVED GREEN COMPRESSION SLEEVE AND REPLACE WITH THE SPARE ONE IN PACK - STILL LEAKING ON FLUSHING AND ASPIRATION AT HUB ASSEMBLY. DR REQUESTED TO OPEN A CS-15232-X 23CM SET TO ACCESS THE HUB ASSEMBLY, AS (B)(6) HOSPITAL DID NOT STOCK (B)(6) HUB REPAIR KIT. AFTER USING NEW HUB ASSEMBLY FROM NEW PACK, THE CATHETER FUNCTIONED PERFECTLY WELL ON FLUSHING AND ASPIRATION OF CATHETER LUMENS, NO LEAKAGE." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "AFTER COMPLETION OF PROCEDURE, ON FLUSHING AND ASPIRATION OF LUMENS, LEAKAGE EXPERIENCED AT HUB ASSEMBLY, DESPITE GREEN COMPRESSION SLEEVE IN PLACE. DR REMOVED GREEN COMPRESSION SLEEVE AND REPLACE WITH THE SPARE ONE IN PACK - STILL LEAKING ON FLUSHING AND ASPIRATION AT HUB ASSEMBLY. DR REQUESTED TO OPEN A CS-15232-X 23CM SET TO ACCESS THE HUB ASSEMBLY, AS ZUID AFRIKAANS HOSPITAL DID NOT STOCK NH-15232 HUB REPAIR KIT. AFTER USING NEW HUB ASSEMBLY FROM NEW PACK, THE CATHETER FUNCTIONED PERFECTLY WELL ON FLUSHING AND ASPIRATION OF CATHETER LUMENS, NO LEAKAGE." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2806308 ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM CATHETER, HEMODIALYSIS, IMPLA MSD ARROW INTERNATIONAL LLC 33F24E0187 00801902096289

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED