BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CANNON II PLUS REPLACEMENT HUB SET

    MDR report key: 23335106 · Received October 20, 2025

    Report

    Report Number
    9680794-2025-00855
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Date of Event
    September 23, 2025
    Report Date
    September 27, 2025
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    NFK
    UDI-DI
    00801902096111
    PMA / PMN Number
    K020430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND ONE POTENTIAL FINDING WAS FOUND; HOWEVER, WITHOUT A PHOTO OR SAMPLE RETURNED, IT CANNOT BE CONFIRMED IF THIS FINDING IS RELEVANT TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THIS KIT INSTRUCTS THE USER, "ALCOHOL, ALCOHOL-BASED SOLUTIONS (E.G. HIBICLENS, CHLORAPREP), IODINE-BASED SOLUTIONS (POVIDONE-IODINE) PEG-BASED OINTMENTS (E.G., BACTROBAN), HYDROGEN PEROXIDE, OR EXSEPT PLUS ARE ACCEPTED FOR USE WITH THIS CATHETER AT THE EXIT SITE (INCLUDING THE JUNCTURE HUB AND CATHETER BODY). ENSURE THAT SOLUTION IS COMPLETELY DRY BEFORE APPLYING AN OCCLUSIVE DRESSING. WARNING: AVOID EXCESSIVE OR PROLONGED USE OF ALCOHOL-BASED SOLUTIONS AND OINTMENTS TO CLEAN CATHETER OR SITE CARE." THE IFU ALSO INSTRUCTS THE USER, "EXAMINE CATHETER AND EXTENSION LINES BEFORE AND AFTER EACH TREATMENT FOR ANY SIGNS OF DAMAGE." 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 23 SEP 2025, THE DOCTOR FOUND LUER HUB/FITTING HAS CRACK DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. 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"(B)(6) 2025, THE DOCTOR FOUND LUER HUB/FITTING HAS CRACK DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. 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
    320309 ARROW CANNON II PLUS REPLACEMENT HUB SET KIT, REPAIR, CATHETER, HEMODI NFK ARROW INTERNATIONAL LLC 33F25C0685 00801902096111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED