BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTRACHEAL TUBE INTRODUCER

    MDR report key: 2623142 · Received March 12, 2010

    Report

    Report Number
    2183650-2010-00002
    Event Type
    Injury
    Date Received
    March 12, 2010
    Date of Event
    January 10, 2010
    Report Date
    March 12, 2010
    Manufacturer
    MEDITEC DEVICES
    Product Code
    BSR
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT UNDERWENT AN ENDOTRACHEAL TUBE EXCHANGE. THE PHYSICIAN PERFORMED THE EXCHANGE AT THE BEDSIDE IN THE CRITICAL CARE UNIT. THE PROCEDURE WAS COMPLETED USING A 15FR X 70 CM ET INTRODUCER. NO COMPLICATIONS WERE PRESENT DURING OR POST PROCEDURE. POST PROCEDURE THE PT HAD EQUAL BREATH SOUNDS BILATERALLY AND CHEST X-RAY VERIFIED THE CORRECT PLACEMENT OF THE ET INTRODUCER. 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 THE OBJECT. A 22CM PIECE OF THE ET INTRODUCER WAS REMOVED FROM THE PT'S TRACHEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTRACHEAL TUBE INTRODUCER ENDOTRACHEAL TUBE INTRODUCER BSR MEDITEC DEVICES MD 016

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention