BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX PLEURAL CATHETER

    MDR report key: 314347 · Received January 25, 2001

    Report

    Report Number
    1717671-2001-00001
    Event Type
    Malfunction
    Date Received
    January 25, 2001
    Date of Event
    December 17, 2000
    Report Date
    January 24, 2001
    Manufacturer
    DENVER BIOMEDICALS, INC.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD PLEURX CATHETER PLACED IN 2000 WITHOUT INCIDENT. FOLLOWING DRAINAGE IN 12/00, A LEAK WAS NOTED. PATIENT EXAMINED 2 DAYS LATER, AND A CRACK APPROX 3MM IN LENGTH WAS NOTED MIDWAY BETWEEN CATHETER EXIT SITE AND THE VALVE ASSEMBLY. PHYSICIAN ASSISTANT WHO REPORTED WAS INTERESTED IN REPAIR KIT. ADVISED COMPLETE REPLACEMENT AND SENT REPLACEMENT CATHETER. HAVE NOT BEEN ABLE TO ASCERTAIN WHETHER THE DEVICE WAS REPLACED. AT TIME OF EXAM, THERE WERE NO SIGNS OF INFECTION OR OTHER ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3050 PLEURX PLEURAL CATHETER PLEURAL DRAINAGE CATHETER KDQ DENVER BIOMEDICALS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO