BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAMAX CHRONIC HEMODIALYSIS CATHETER

    MDR report key: 2010206 · Received February 11, 2011

    Report

    Report Number
    1319211-2011-00013
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 14, 2011
    Report Date
    February 11, 2011
    Manufacturer
    ANGIODYNAMICS
    Product Code
    MSD
    PMA / PMN Number
    K080400
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE REPORTED DEFECTIVE DEVICE WAS DISPOSED OF BY THE END USER, AN INVESTIGATION INTO THE ROOT CAUSE OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2011 BY THE END USER, WHILE TUNNELING A DIALYSIS CATHETER, THE PLASTIC SLEEVE ON THE METAL TUNNELER BROKE. THERE WAS NO HARM TO THE PATIENT AND NO FURTHER MEDICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAMAX CHRONIC HEMODIALYSIS CATHETER DIALYSIS CATHETER MSD ANGIODYNAMICS NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1