BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTRACHEAL TUBE INTRODUCER

    MDR report key: 1624635 · Received March 4, 2010

    Report

    Report Number
    0001036445-2010-01030
    Event Type
    Injury
    Date Received
    March 4, 2010
    Date of Event
    January 10, 2010
    Report Date
    March 4, 2010
    Manufacturer
    MEDITEC DEVICES, 1A MITUL INDUSTRIAL ESTATE
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), 2010, PT UNDERWENT AN ENDOTRACHEAL TUBE EXCHANGE USING THE ENDOTRACHEAL TUBE INTRODUCER. NO COMPLICATIONS OCCURRED DURING OR POST THE PROCEDURE. POST PROCEDURE THE PT HAD EQUAL BREATH SOUNDS BILATERALLY AND CHEST X-RAY VERIFIED CORRECT PLACEMENT OF THE ENDOTRACHEAL TUBE. A DAY LATER, ON (B)(6), 2010, THE CRITICAL CARE RN ENCOUNTERED SOME DIFFICULTY DURING PT SUCTIONING. A BRONCHOSCOPY REVEALED A BLUE RINGED OBJECT IN THE PT'S TRACHEA. PT WAS TAKEN TO SURGERY AND UNDERWENT A BRONCHOSCOPY TO REMOVE A 22CM (1/3 OF THE INTRODUCER USED PREVIOUS DAY) PIECE OF ENDOTRACHEAL TUBE INTRODUCER. THE ORIGINAL LENGTH OF THE INTRODUCER WAS 70CM. PT TOLERATED THE PROCEDURE WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTRACHEAL TUBE INTRODUCER ENDOTRACHEAL TUBE INTRODUCER BTR MEDITEC DEVICES, 1A MITUL INDUSTRIAL ESTATE MD016

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention