BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2-L HUB CONNECT ASSY REPLACEMENT SET

    MDR report key: 2483344 · Received February 20, 2012

    Report

    Report Number
    1036844-2012-00054
    Event Type
    Malfunction
    Date Received
    February 20, 2012
    Date of Event
    January 30, 2012
    Report Date
    February 28, 2012
    Manufacturer
    ARROW INTERNATIONAL 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

    SEE MDR# 1036844-2012-00053 FOR THE FIRST EVENT INVOLVING THE SAME PT. IT WAS REPORTED THAT THE HUB REPAIR KIT THAT WAS USED IN (B)(6) 2012 BEGAN TO LEAK DURING DIALYSIS ON (B)(6) 2012. THE LEAK WAS OBSERVED FROM THE ARTERIAL AND VENOUS PORTS. AS A RESULT, A REPAIR KIT WAS USED. THERE WAS NO DELAY IN TREATMENT, NO PT DEATH, AND NO PT COMPLICATIONS WERE REPORTED. NO LEAKS WERE OBSERVED DURING DIALYSIS SINCE THE NEW REPAIR KIT WAS USED.

    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 INTERNATIONAL INC RF1082462

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR