BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2-L HUB CONNECT ASSY REPLACEMENT SET

    MDR report key: 3005968 · Received January 29, 2013

    Report

    Report Number
    1036844-2013-00038
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 1, 2012
    Report Date
    January 28, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    NFK
    PMA / PMN Number
    K020430
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW UP 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 ARE BREAKING EASILY. AS A RESULT, A NEW REPAIR KIT WAS USED TO CORRECT THE ISSUE. THE CONNECTORS WERE MAT(DULL FINISH) BEFORE AND ARE NOW BRILLIANT (SHINY FINISH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38872 2-L HUB CONNECT ASSY REPLACEMENT SET CHRONIC HEMODIALYSIS CATHETER PRODUCTS NFK ARROW INTL., INC. RF9096856

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK