BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX PLEURAL CATHETER

    MDR report key: 349765 · Received August 21, 2001

    Report

    Report Number
    1717671-2001-00005
    Event Type
    Malfunction
    Date Received
    August 21, 2001
    Date of Event
    July 10, 2001
    Manufacturer
    DENVER BIOMEDICAL, INC.
    Product Code
    KPM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INTERCOSTAL DRAIN TO PLEURAL SPACE WAS BEING REMOVED. AS THE DEVICE WAS GRABBED AND BEING PULLED OUT OF THE PT'S BODY, THE DISTAL BROKE OFF. A PORTION OF THE CATHETER REMAINS IMPLANTED AND WILL NOT BE REMOVED. PER THE RN, THE REMAINING PORTION OF THE CATHETER WAS NOT REMOVED DUE TO THE AGE AND CONDITION OF THE PT AND POSES NO HEALTH RISK TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38454 PLEURX PLEURAL CATHETER PLEURAL CATHETER KPM DENVER BIOMEDICAL, INC. 50-7000 993238

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR