BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2-L HUB CONNECT ASSY REPLACEMENT SET

    MDR report key: 2542932 · Received April 5, 2012

    Report

    Report Number
    1036844-2012-00090
    Event Type
    Malfunction
    Date Received
    April 5, 2012
    Date of Event
    April 2, 2012
    Report Date
    April 5, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    NFK
    PMA / PMN Number
    K020430
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    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 THAT THE PROCEDURE WAS BEING PERFORMED IN A DIALYSIS PT WITH A RIGHT INTERNAL JUGULAR VEIN PERMANENT DIALYSIS CATHETER IN THE RENAL UNIT. IT WAS NOTICED THAT THE BLUE PORT ON THE EXTERNAL PIGTAIL HAD A CRACK IN IT WHEN ATTEMPTING TO PERFORM DIALYSIS FOR THE PT. DIALYSIS COULD NOT BE PERFORMED DUE TO THE FACT THAT THE CATHETER WAS SUCKING AIR AND PRESSURES COULD NOT BE MAINTAINED. AS A RESULT, A REPAIR KIT WAS USED TO REPLACE THE LUMENS AND DIALYSIS TOOK PLACE AS PLANNED. THERE WAS NO DELAY IN TREATMENT, NO PT DEATH, AND NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2-L HUB CONNECT ASSY REPLACEMENT SET CHRONIC HEMODIALYSIS CATHETER PRODUCTS NFK ARROW INTL., INC. RF0088465

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK