BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAMAX CHRONIC HEMODIALYSIS CATHETER

    MDR report key: 3874950 · Received June 11, 2014

    Report

    Report Number
    1319211-2014-00082
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    ANGIODYNAMICS
    Product Code
    MSD
    PMA / PMN Number
    K080400
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEFECT DEVICE HAS BEEN RETURNED TO THE MANUFACTURER. AN INVESTIGATION INTO THE ROOT CAUSE OF THIS INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION AND ANY FOLLOW UP INFORMATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. A REVIEW OF THE LOT HISTORY RECORDS WAS PERFORMED FOR THE REPORTED LOT FOR ANY DEVIATIONS. THE REVIEW CONFIRMS THAT TH LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. (B)(4) .

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2014, A (B)(6) MALE PATIENT PRESENTED FOR A DIALYSIS PROCEDURE. DURING THE PROCEDURE, THE TUNNELER SLEEVE FRACTURED OFF INSIDE OF THE PATIENT. THE FRACTURED PIECE WAS SUCCESSFULLY RETRIEVED. THERE WAS NO PERMANENT HARM OR INJURY TO THE PATIENT DUE TO THE EVENT. THE REPORTED DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE IS CURRENTLY IN PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343872 DURAMAX CHRONIC HEMODIALYSIS CATHETER CHRONIC HEMODIALYSIS CATHETER MSD ANGIODYNAMICS 599602

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention