BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2-L HUB CONNECT ASSY REPLACEMENT SET

    MDR report key: 3061276 · Received April 10, 2013

    Report

    Report Number
    1036844-2013-00141
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    February 1, 2013
    Report Date
    April 8, 2013
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    NFK
    PMA / PMN Number
    K020430
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 IN A GENERAL COMPLAINT THAT DURING THERAPIES, THEY ALLEGE THE CLAMPS BREAK VERY OFTEN. AS A RESULT, THEY ARE EXCHANGED. THERE HAVE BEEN NO PT DEATHS OR COMPLICATIONS REPORTED. IT IS NOT KNOWN HOW MANY TIMES THIS HAS OCCURRED. IT WAS NOTED THEY FEEL THE MATERIAL OF THE CLAMPS IS TOO HARD COMPARED TO COMPETITORS' CLAMPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148400 2-L HUB CONNECT ASSY REPLACEMENT SET CHRONIC HEMODIALYSIS CATHETER PRODUCTS NFK ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK