BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACIC SILICONE CATHETER RIGHT ANGLE 32 FR

    MDR report key: 186389 · Received September 3, 1998

    Report

    Report Number
    186389
    Event Type
    Malfunction
    Date Received
    September 3, 1998
    Date of Event
    July 31, 1998
    Report Date
    August 4, 1998
    Manufacturer
    AXIOM MEDICAL, INC.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 7/28/98 SENT PT TO OPERATING ROOM, PLACED PERICARDIAL WINDOW WITH 2 MEDIASTINAL TUBES TO DRAIN EXCESS FLUID. ON 7/31/98 ONE TUBE REMOVED WITHOUT INCIDENT. WHEN SECOND TUBE REMOVED, IT WAS NOTED TO BE SHORTER. CHEST X-RAY OBTAINED AND PORTION OF TUBE SHOWN TO HAVE REMAINED IN PT. THE PT WAS TAKEN TO OPERATING ROOM FOR RETRIEVAL OF TUBE. BREAKAGE PROBABLY AT SITE OF DRAINAGE HOLE. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORACIC SILICONE CATHETER RIGHT ANGLE 32 FR CHEST TUBE KDQ AXIOM MEDICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR