BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNON II PLUS REPLACEMENT HUB SET

    MDR report key: 3922241 · Received June 3, 2014

    Report

    Report Number
    1036844-2014-00249
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 22, 2014
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    NFK
    PMA / PMN Number
    K020430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT INVOLVED WAS A (B)(6) MALE WITH A HISTORY OF RENAL FAILURE, CATHETERIZED SINCE 2009, AND ON HIS THIRD REPAIR KIT. IN THE RENAL UNIT DURING DIALYSIS, THE HUB OF THE CATHETER PLACED IN THE PATIENT'S RIGHT INTERNAL JUGULAR VEIN WAS FOUND LEAKING AT THE HUB. AS A RESULT, A NEW REPAIR KIT WAS SUCCESSFULLY USED TO SOLVE THE ISSUE. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323187 CANNON II PLUS REPLACEMENT HUB SET CHRONIC HEMODIALYSIS CATHETER PRODUCTS NFK ARROW INTERNATIONAL INC. FR1045472

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR