BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11467078 · Received March 11, 2021

    Report

    Report Number
    1036844-2021-00053
    Event Type
    Malfunction
    Date Received
    March 11, 2021
    Date of Event
    February 4, 2021
    Report Date
    February 25, 2021
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    MSD
    PMA / PMN Number
    K141051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE CUSTOMER RETURNED ONE HEMODIALYSIS CATHETER FOR ANALYSIS. SIGNS-OF-USE IN THE FORM OF BIOLOGICAL MATERIAL WAS OBSERVED ON THE CATHETER BODY. VISUAL ANALYSIS REVEALED THAT A PORTION OF THE ARTERIAL EXTENSION LINE CONTAINED A TEAR DIRECTLY AT THE CONNECTION POINT BETWEEN THE EXTENSION LINE AND THE JUNCTURE HUB. THE APPEARANCE OF THE TEAR APPEARS JAGGED. MICROSCOPIC EXAMINATION REVEALED A HOLE AT THE TEAR. THE CATHETER BODY TOTAL LENGTH MEASURED 9.5", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 9.17"-9.73" PER THE CATHETER GRAPHIC. THE ARTERIAL EXTENSION LINE OUTER DIAMETER MEASURED .186", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .185"-.191" PER THE EXTENSION LINE EXTRUSION GRAPHIC. THE ARTERIAL EXTENSION LINE INNER DIAMETER AT THE PROXIMAL END MEASURED .124", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .120"-.126" PER THE EXTENSION LINE EXTRUSION GRAPHIC. WITH THE DISTAL END OF THE CATHETER BODY OCCLUDED, A LAB INVENTORY SYRINGE FILLED WITH WATER WAS ATTACHED TO BOTH EXTENSION LINES AND ASPIRATED. A LEAK WAS OBSERVED AT THE CONNECTION POINT BETWEEN THE ARTERIAL EXTENSION LINE AND THE JUNCTURE HUB. NO LEAKS WERE OBSERVED AT THE VENOUS EXTENSION LINE. PERFORMED PER IFU STATEMENT, "ESTABLISH AND MAINTAIN CATHETER PATENCY. SOLUTION AND FREQUENCY OF FLUSHING A VENOUS ACCESS CATHETER SHOULD BE ESTABLISHED IN HOSPITAL/INSTITUTIONAL POLICY". MANUFACTURING AND ENGINEERING WERE CONTACTED AS PART OF THIS COMPLAINT INVESTIGATION. BOTH PARTIES INDICATED THAT MANUFACTURING LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "DO NOT APPLY EXCESSIVE FORCE IN PLACING OR REMOVING CATHETER OR GUIDEWIRE. EXCESSIVE FORCE CAN CAUSE COMPONENT DAMAGE OR BREAKAGE. IF DAMAGE IS SUSPECTED OR WITHDRAWAL CANNOT BE EASILY ACCOMPLISHED, RADIOGRAPHIC VISUALIZATION SHOULD BE OBTAINED AND FURTHER CONSULTATION REQUESTED". THE IFU ALSO STATES, "DO NOT USE IF PACKAGE IS DAMAGED". THE REPORT OF A LEAKING EXTENSION LINE WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION. VISUAL ANALYSIS REVEALED A TEAR DIRECTLY ADJACENT TO THE CONNECTION POINT BETWEEN THE ARTERIAL EXTENSION LINE AND THE JUNCTURE HUB. MICROSCOPIC EXAMINATION CONFIRMED THE DAMAGE AND REVEALED A HOLE. WATER WAS OBSERVED LEAKING OUT OF THIS HOLE WHEN FUNCTIONALLY TESTING THE SAMPLE. DESPITE THE DAMAGE, THE CATHETER MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. BASED ON THE CUSTOMER REPORT, THE SAMPLE RECEIVED, AND THE COMMENTS FROM MANUFACTURING/ENGINEERING , MANUFACTURING LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. A NON-CONFORMANCE REQUEST WAS INITIATED TO FURTHER INVESTIGATE THIS COMPLAINT ISSUE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: "CATHETERISATION DONE ON (B)(6) 2020 AND UNDERGONE DIALYSIS. FOUND LEAKAGE IN LUMEN NOW". IT WAS REPORTED THE PATIENT HAD TO UNDERGO RE-CATHETERISATION. PATIENT REPORTED TO BE FINE. DELAY TO TREATMENT WAS REPORTED HOWEVER.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: "CATHETERISATION DONE ON (B)(6) 2020 AND UNDERGONE DIALYSIS. FOUND LEAKAGE IN LUMEN NOW". IT WAS REPORTED THE PATIENT HAD TO UNDERGO RE-CATHETERISATION. PATIENT REPORTED TO BE FINE. DELAY TO TREATMENT WAS REPORTED HOWEVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358764 ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM ANTE CATHETER, HEMODIALYSIS, IMPLA MSD ARROW INTERNATIONAL INC. 23F19G0022

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEMODIALYSIS| HEMODIALYSIS