BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORACENTSIS/PARACENTESIS KIT

    MDR report key: 365704 · Received December 14, 2001

    Report

    Report Number
    1423507-2001-00286
    Event Type
    Death
    Date Received
    December 14, 2001
    Report Date
    December 14, 2001
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Product Code
    GCB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    1. STYLET TOO LONG - ONCE IN CHEST CAVITY, CAN BE TOO CLOSE TO ORGANS; 2. STYLET BLUNT SO DOCTOR USED FORCE TO PUSH IT THROUGH THE CHEST WALL - ORGANS AT RISK. FURTHER COMMUNICATION REVEALED THAT PACK WAS USED ON A PT FOR A PLEURAL TAP PT WENT INTO CARDIAC ARREST 20 MINS LATER, AND THEY WERE UNABLE TO RESUSCITATE. AN AUTOPSY SHOWED PERFORATION OF THE LEFT VENTRICLE WITH CARDIAC TAMPONADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56591 THORACENTSIS/PARACENTESIS KIT THORACENTSIS TRAY GCB ALLEGIANCE HEALTHCARE CORP. TPK1001 LIB037

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death