BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAMAX CHRONIC HEMODIALYSIS CATHETER

    MDR report key: 1961497 · Received January 10, 2011

    Report

    Report Number
    1319211-2011-00001
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 7, 2010
    Report Date
    January 6, 2011
    Manufacturer
    ANGIODYNAMICS
    Product Code
    MSD
    PMA / PMN Number
    K080400
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEFECTIVE DEVICE WAS RETURNED ON (B)(4) 2010. AN INVESTIGATION INTO THE ROOT CAUSE FOR THIS INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A F/U MEDWATCH. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE END USER ON (B)(6) 2010, WHILE TUNNELING A DIALYSIS CATHETER, THE "WHITE PLASTIC COVER THAT SLIDES DOWN OVER THE TUNNELER AND CATHETER HAS SHATTERED INTO MULTIPLE PLASTIC SHARDS." F/U WITH THE END USER NOTED THAT THERE WAS NO HARM DONE TO THE PT AND NO FURTHER MEDICAL INTERVENTION WAS REQUIRED TO RETRIEVE THE PLASTIC SHARDS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAMAX CHRONIC HEMODIALYSIS CATHETER DIALYSIS CATHETER MSD ANGIODYNAMICS NA 527756

    Patients

    Seq Age Sex Outcome Treatment
    1