BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX PLEURAL CATHETER KIT

    MDR report key: 335481 · Received May 30, 2001

    Report

    Report Number
    1717671-2001-00004
    Event Type
    Malfunction
    Date Received
    May 30, 2001
    Date of Event
    March 1, 2001
    Report Date
    May 23, 2001
    Manufacturer
    DENVER BIOMEDICAL, INC.
    Product Code
    KPM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING DRAINAGE PROCEDURE, THE VALVE ASSEMBLY CAME LOOSE AND DISCONNECTED FROM THE CATHETER. THE VALVE WAS RE-INSERTED INTO THE CATHETER AND TAPED IN PLACE. AS A PRECAUTION, THE CATHETER WAS CLAMPED BETWEEN DRAINAGE PROCEDURES. NO ADVERSE EFFECTS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24879 PLEURX PLEURAL CATHETER KIT CATHETER KPM DENVER BIOMEDICAL, INC. 50-7050 991909

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN