BEUDAMED
    FDA Adverse Event Summary report: N

    THORACIC SILICONE CATHETER

    MDR report key: 19045 · Received January 19, 1995

    Report

    Report Number
    MW1004797
    Date Received
    January 19, 1995
    Date of Event
    December 21, 1994
    Report Date
    January 9, 1995
    Manufacturer
    AXIOM MEDICAL, INC.
    Product Code
    KDQ
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AIR LEAK WAS NOTICED IN DRAINAGE CONTAINER. CHEST TUBE DRESSING WAS REMOVED, AND LEFT MEDIASTINAL CHEST TUBE WAS FOUND CRACKED AND BROKEN AT THE SITE OF THE CLAMP. HEMOSTATS WERE USED TO CLAMP CHEST TUBE ON PT SIDE. CONNECTOR USED TO CONNECT CHEST TUBE TO CONTAINER RUBBER TUBING. CHEST TUBE AGAIN BROKE AT CONNECTOR. HEMOSTATS USED TO CLAMP TUBE AGAIN WHICH BROKE AT HEMOSTATS. TUBE AGAIN CLAMPED WITH HEMOSTATS AND PLUGGED WITH VASELINE GAUZE UNTIL PHYSICIAN COULD REMOVE BROKEN CHEST TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORACIC SILICONE CATHETER THORACIC CHEST TUBE KDQ AXIOM MEDICAL, INC. 9410883

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR