BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMVENT MIRCROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBES

    MDR report key: 3973233 · Received July 9, 2014

    Report

    Report Number
    3973233
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 20, 2014
    Report Date
    July 7, 2014
    Manufacturer
    KIMBERLY CLARK CORPORATION
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING INITIAL ASSESSMENT OF PATIENT, PILOT BALLOON WAS MISSING FROM ENDOTRACHEAL TUBE (ETT). CALLED NIGHT SHIFT RT AND RN AND WAS INFORMED RN FOUND PILOT BALLOON IN PATIENT'S LINEN AND DISPOSED OF IT. CUFF OF ETT WAS DEFLATED AND LEAK WAS PRESENT AT THIS TIME. THIS IS A SUBGLOTTIC SUCTION ENDOTRACHEAL TUBE, WITH NO LOT NUMBER ON THE TUBE. NEW PACKAGE WAS OPENED AND THE PILOT BALLOON WAS TUGGED ON AND IT SEPARATED FROM THE CHANNEL ON THE ENDOTRACHEAL TUBE MORE EASILY THAN THE STANDARD ENDOTRACHEAL TUBE WHICH CAUSED THE PILOT BALLOON TO BE STRETCHED LONGER BUT NOT SEPARATED FROM THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400715 KIMVENT MIRCROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBES TUBE, TRACHEAL (W/WO CONNECTOR) BTR KIMBERLY CLARK CORPORATION 8.0 MM ADULT *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR NO OTHER THERAPIES