BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOOTHETTE SUCTION

    MDR report key: 3221232 · Received June 28, 2013

    Report

    Report Number
    3221232
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 28, 2013
    Manufacturer
    SAGE PRODUCTS, LLC
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING ORAL CARE, A 2 TO 2.5 INCH PIECE OF THE SUBGLOTTAL SUCTION TUBING BROKE OFF AND WAS LODGED IN THE PATIENT'S THROAT. RN WAS UNABLE TO VISUALIZE THE BROKEN PIECE TO REMOVE THE OBJECT. UPON INSPECTION, THE SUCTION CATHETER APPEARED TO BE PERFORATED WHERE IT BROKE OFF. PT WAS INTUBATED AT THE TIME. THE SURGICAL ICU RESIDENT WAS CALLED TO THE BEDSIDE AND THEY WERE UNSUCCESSFUL AT FINDING THE OBJECT. CHEST XRAY AND KUB WERE ORDERED AND NO FOREIGN OBJECTS WERE SEEN ON THESE FILMS. ALL SUBGLOTTAL SUCTION TUBINGS FROM KIT WERE REMOVED AND DISCARDED. NO APPARENT PATIENT HARM. THE PIECE MISSING FROM THE END OF THE TUBING WAS UNABLE TO BE LOCATED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ORAL CARE FOR AN INTUBATED PATIENTDEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295572 TOOTHETTE SUCTION CATHETER AND TIP, SUCTION JOL SAGE PRODUCTS, LLC * 38552

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR