BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVENMORE CHRONIC HEMODIALYSIS CATHETER

    MDR report key: 3063158 · Received February 27, 2013

    Report

    Report Number
    1319211-2013-00020
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    October 28, 2012
    Report Date
    February 1, 2013
    Manufacturer
    ANGIODYNAMICS
    Product Code
    MSD
    PMA / PMN Number
    K003207
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DISPOSABLE DEVICE WAS DISCARDED BY THE USER AND IS NOT AVAILABLE TO BE RETURNED TO THE MFR FOR EVAL. A REVIEW OF THE LOT HISTORY RECORDS WAS PERFORMED FOR THE REPORTED PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. AN INVESTIGATION INTO THE ROOT CAUSE OF THIS INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE DEVICE EVAL WILL BE SENT VIA A F/U MEDWATCH. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2013, ON (B)(6) 2012, A PT OF UNK AGE AND GENDER PRESENTED FOR A HEMODIALYSIS CATHETER PLACEMENT. THERE WAS NO REPORT OR COMPLICATIONS OR DEVICE FAILURE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS REPORTED THAT CHLOROHEXIDINE WAS USED FOR THE INSERTION SITE CARE, AND NO ACETONE WAS USED ON THE DEVICE. APPROX EIGHT MONTHS POST PROCEDURE, IT WAS REPORTED THE CATHETER WAS LEAKING UNDER THE HUB TO THE DISTAL SIDE ON THE ARTERY SIDE. IT WAS REPORTED THAT THE BLOOD LOSS WAS MINIMAL. THE DEFECTIVE DEVICE WAS REMOVED AND REPLACED WITH A NEW OF THE SAME DEVICE. IT WAS REPORTED THE PT IS DOING WELL AND HAS SUFFERED NO HARM OR INJURY DUE TO THE EVENT. IT WAS REPORTED THE DEVICE IS AVAILABLE FOR RETURN TO THE MFR FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84521 EVENMORE CHRONIC HEMODIALYSIS CATHETER CHRONIC HEMODIALYSIS CATEHTER MSD ANGIODYNAMICS 565091

    Patients

    Seq Age Sex Outcome Treatment
    1