BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRAUM

    MDR report key: 1233016 · Received November 11, 2008

    Report

    Report Number
    1233016
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    November 9, 2008
    Report Date
    November 11, 2008
    Manufacturer
    AXIOM MEDICAL INC.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS ATTEMPTING TO REMOVE LEFT PLEURAL CHEST TUBE AT THE BEDSIDE OF A SEDATED PATIENT. DURING GENTLE EXTRACTION OF THE TUBE, A PORTION OF THE TUBE BROKE AND SEPARATED REMAINING BEHIND IN THE PATIENT. CHEST X-RAY WAS ORDERED TO DETERMINE LOCATION OF TUBE AND PATIENT WAS SCHEDULED FOR SURGERY TO EXTRACT REMAINING TUBE. SURGERY WAS PERFORMED AND THE REMAINING TUBE SECTION RETRIEVED AND SENT TO BIOMEDICAL FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRAUM 20 FRENCH THORACIC ANGLE SILICONE CATHETER KDQ AXIOM MEDICAL INC. ATRAUM 0506602

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR OTHER| OTHER