BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2-L HUB CONNECT ASSY REP LACEMENT SET

    MDR report key: 2975640 · Received February 7, 2013

    Report

    Report Number
    1036844-2013-00051
    Event Type
    Malfunction
    Date Received
    February 7, 2013
    Date of Event
    January 1, 2012
    Report Date
    February 5, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    NFK
    PMA / PMN Number
    K020430
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROCEDURE WAS BEING PERFORMED IN THE DIALYSIS DEPARTMENT. THE BLUE AND RED PINCH CLAMPS BROKE EASILY. AS A RESULT, A NEW REPAIR KIT WAS USED TO CORRECT THE ISSUE. F/U INFO CONFIRMS THE BREAKAGE OCCURRED AFTER SEVERAL WEEKS OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53225 2-L HUB CONNECT ASSY REP LACEMENT SET CHRONIC HEMODIALYSIS CATHETER PRODUCTS NFK ARROW INTL., INC. RF9096856

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK