BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER, TUNNELED

    MDR report key: 2121012 · Received June 6, 2011

    Report

    Report Number
    2121012
    Event Type
    Malfunction
    Date Received
    June 6, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 31, 2011
    Manufacturer
    ARROW
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT HAD A DIALYSIS CATHETER PLACED TWO MONTHS AGO AND IS PRESENTING WITH LOW FLOW RATES. THE CATHETER WAS CHANGED OUT FOR ANOTHER AND THE REPLACEMENT CATHETER IS WORKING FINE. THERE IS A POSSIBILITY THAT THERE MAY BE A MANUFACTURER DEFECT FROM THE TUNNLED CATHETER ITSELF. PLEASE SEND TO MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER, TUNNELED CATHETER MSD ARROW * RC0128278

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR DIALYSIS