BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2-L HUB CONNECT ASSY REP LACEMENT SET

    MDR report key: 2538079 · Received April 9, 2012

    Report

    Report Number
    1036844-2012-00094
    Event Type
    Malfunction
    Date Received
    April 9, 2012
    Date of Event
    March 16, 2012
    Report Date
    April 9, 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). SAMPLE WILL NOT BE RETURNED.

    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 THERE WAS A CRACK IN THE EXTERNAL BLUE LUER LOCK CONNECTOR WHERE YOU ATTACH TO THE DIALYSIS LINE. 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. IT WAS NOTED THAT THIS PRODUCT PART HAD BEEN IN USE FOR MORE THAN A YR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK