BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORACENTESIS CATHETER

    MDR report key: 33007 · Received May 15, 1996

    Report

    Report Number
    MW1009103
    Event Type
    Injury
    Date Received
    May 15, 1996
    Date of Event
    April 11, 1996
    Report Date
    April 24, 1996
    Manufacturer
    PHARMASEAL DIV. BAXTER HEALTHCARE CORP.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A THORACENTESIS DUE TO A LARGE RIGHT PLEURAL EFFUSION. UPON WITHDRAWAL OF THE THORACENTESIS NEEDLE, A PORTION OF THE CATHETER REMAINED INSIDE THE RIGHT CHEST. THIS THEN STINTED THE HOLE OPEN WHICH ALLOWED FOR AIR TO BECOME A SUB-PNEUMONIC PNEUMOTHORAX ON THE RIGHT. THE PORTION OF THE CATHETER WAS SUCCESSFULLY REMOVED AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORACENTESIS CATHETER THORACENTESIS CATHETER KDQ PHARMASEAL DIV. BAXTER HEALTHCARE CORP. L5N054

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R