BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CANNON II PLUS REPLACEMENT HUB SET

    MDR report key: 20127710 · Received September 3, 2024

    Report

    Report Number
    9680794-2024-00852
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Date of Event
    August 12, 2024
    Report Date
    August 13, 2024
    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

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE CONNECTOR ASSEMBLY FOR ANALYSIS. IT WAS NOTED THAT THE COMPRESSION FITTING, THE GREEN SLEEVE, AND A SECTION OF THE CATHETER BODY WERE FIXED TO THE JUNCTURE HUB OF THE CONNECTOR ASSEMBLY. SIGNS OF USE WERE OBSERVED. VISUAL ANALYSIS REVEALED THE RED ARTERIAL LUER HUB AND THE BLUE VENOUS LUER HUB CONTAINED A CRACK. STRESS MARKS WERE ALSO NOTED AROUND THE THREADS. MICROSCOPIC EXAMINATION CONFIRMED THE DAMAGE. THE APPEARANCE OF THIS DAMAGE IS CONSISTENT WITH OVERTIGHTENING OR REPEATED TIGHTENING OF THE HUBS. NO DEFECTS OR ANOMALIES WERE OBSERVED ON ANY OTHER PORTION OF THE RETURNED DEVICE. BOTH LUER CONNECTIONS WERE FUNCTIONALLY TESTED PER THE PRODUCT INSTRUCTIONS-FOR-USE (IFU). THE IFU PROVIDED WITH THIS KIT INSTRUCTS THE USER, "ESTABLISH AND MAINTAIN CATHETER PATENCY. SOLUTION AND FREQUENCY OF FLUSHING A VENOUS ACCESS CATHETER SHOULD BE ESTABLISHED IN HOSPITAL/INSTITUTIONAL POLICY". A LAB INVENTORY SYRINGE FILLED WITH WATER WAS USED TO FLUSH EACH EXTENSION LINE. WHEN FLUSHING BOTH THE VENOUS AND ARTERIAL EXTENSION LINE, WATER WAS OBSERVED LEAKING FROM THE CRACKS. A MANUAL TUG TEST CONFIRMED BOTH LUER HUB WERE SECURELY ATTACHED TO THE RESPECTIVE LUMENS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "REPEATED OVER TIGHTENING OF BLOODLINES , SYRINGES AND CAPS WILL REDUCE CONNECTOR LIFE AND COULD LEAD TO POTENTIAL CONNECTOR FAILURE". THE REPORT OF A CRACKED LUER HUB WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. VISUAL ANALYSIS REVEALED THAT THE RED ARTERIAL AND THE BLUE VENOUS LUER HUBS CONTAINED A CRACK AND DAMAGE CONSISTENT WITH OVERTIGHTENING OR REPEATED TIGHTENING OF THE HUBS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. BASED ON THE CUSTOMER REPORT AND THE SAMPLE RECEIVED , UNINTENTIONAL USE ERROR LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED "THE DOCTOR FOUND THE LUER HUB DAMAGED DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW SET. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CONDITION IS REPORTED AS "FINE".

    Description of Event or Problem · 0

    IT WAS REPORTED "THE DOCTOR FOUND THE LUER HUB DAMAGED DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW SET. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CONDITION IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701325 ARROW CANNON II PLUS REPLACEMENT HUB SET KIT, REPAIR, CATHETER, HEMODI NFK ARROW INTERNATIONAL LLC 33F23C0882 00801902096111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NONE REPORTED.| NONE REPORTED.