BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW-CLARK VECTORFLOW HEMODIALYSIS CATHETER

    MDR report key: 9322806 · Received November 14, 2019

    Report

    Report Number
    9680794-2019-00470
    Event Type
    Malfunction
    Date Received
    November 14, 2019
    Date of Event
    November 1, 2019
    Report Date
    November 4, 2019
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    MSD
    PMA / PMN Number
    K141051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE SAMPLE WAS NOT RETURNED; HOWEVER, THE CUSTOMER PROVIDED ONE PHOTO AND VIDEO FOR EVALUATION. THE PHOTO SHOWED A LEAK NEAR THE EXTENSION LINE/JUNCTURE HUB AREA. THE LEAK WAS CONFIRMED BY THE CUSTOMER VIDEO. HOWEVER, WITHOUT THE RETURNED DEVICE, VISUAL INSPECTION CANNOT BE COMPLETED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THIS KIT WARNS 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 REPORT THAT THE JUNCTURE HUB LEAKED WAS CONFIRMED THROUGH EXAMINATION OF THE CUSTOMER SUPPLIED PHOTO AND VIDEO. THE IMAGE AND VI DEO SHOWED THE LEAKING; HOWEVER, THE ACTUAL COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY REVIEW WAS COMPLETED WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THE PROBABLE CAUSE OF THE LEAKING COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT THE ACTUAL COMPLAINT SAMPLE RETURNED FOR EVALUATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS THAT THE HUB IS LEAKING. THE DEVICE WAS REPLACED, AND THE ISSUE WAS RESOLVED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE HUB IS LEAKING. THE DEVICE WAS REPLACED, AND THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1117494 ARROW-CLARK VECTORFLOW HEMODIALYSIS CATHETER CATHETER, HEMODIALYSIS, IMPLA MSD ARROW INTERNATIONAL INC. IPN001356 13F19E0258

    Patients

    Seq Age Sex Outcome Treatment
    1