BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORACENTESIS NEEDLE CATHETER TRAY

    MDR report key: 5480477 · Received March 4, 2016

    Report

    Report Number
    5480477
    Event Type
    Injury
    Date Received
    March 4, 2016
    Date of Event
    August 8, 2015
    Report Date
    January 19, 2016
    Manufacturer
    CAREFUSION 2200, INC.
    Product Code
    GCB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING THORACENTESIS USING CATHETER FROM CAREFUSION THORACENTESIS TRAY WITH CATHETER, CATALOG NUMBER 4341B. DURING THE PLACEMENT, IT WAS NOTED THAT AIR WAS ASPIRATING DESPITE THE NEEDLE BEING INSERTED INSIDE THE SKIN. SHORTLY THEREAFTER PATIENT'S BLOOD PRESSURE DROPPED AND PULSE LOST. AIRWAY MANAGED, SHORT CPR, 14 GAUGE USED TO DECOMPRESS CHEST. SATS AND HR QUICKLY RECOVERED; PATIENT THEN INTUBATED AND CHEST TUBE PLACED. CHEST X-RAY CONFIRMED CLINICALLY-SUSPECTED PNEUMOTHORAX. MORE INFO: THORACENTESIS CATHETER, BEING PLACED FOR IATROGENIC PNEUMOTHORAX, DID NOT FUNCTION AS EXPECTED (AIR LEAK - MD DOES NOT BELIEVE IT WAS USER ERROR). BIOMED PAGED TO RETRIEVE DEVICE. PT. HAS LUNG CANCER ON SAME SIDE. INTUBATION WOULD HAVE OCCURRED DESPITE SUSPECTED CATHETER MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135858 THORACENTESIS NEEDLE CATHETER TRAY NEEDLE, CATHETER, THORACENTESIS TRAY GCB CAREFUSION 2200, INC. 4341B UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other