BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORACENTESIS TRAY WITH CATHETER

    MDR report key: 1408699 · Received June 29, 2009

    Report

    Report Number
    MW5011694
    Event Type
    Injury
    Date Received
    June 29, 2009
    Date of Event
    June 25, 2009
    Report Date
    June 29, 2009
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KDQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RESIDENT PERFORMED THORACENTESIS AND WHEN HE GRASPED AND PULLED THE NEEDLE, THE CATHETER DID NOT FOLLOW THE NEEDLE. CATHETER IS INSIDE OF PT AND PT HAS TOO MANY RISKS TO UNDERGO GENERAL SURGERY TO REMOVE THE CATHETER. SMALL CRACK SEN IN WHITE TUBING DISTAL TO NEEDLE ON THE ACTUAL KIT RELATED TO THIS EVENT. I OPENED UP ANOTHER KIT AND SAW A BIGGER "CRACK" IN THE SAME AREA. SECOND KIT HAS NEEDLE GUARD, WHICH DOES NOT EASILY CLOSE. DATES OF USE: 2009 - 10 MINUTES. DIAGNOSIS OR REASON FOR USE: MODERATE TO SEVERE BILATERAL PLEURAL EFFUSION LEFT > RIGHT RESPIRATORY DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORACENTESIS TRAY WITH CATHETER THORACENTESIS TRAY WITH CATHETER KDQ CARDINAL HEALTH L9B288
    2 THORACENTESIS TRAY WITH CATHETER THORACENTESIS TRAY WITH CATHETER KDQ CARDINAL HEALTH L8L295

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other