BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE INTRODUCER

    MDR report key: 1637598 · Received March 16, 2010

    Report

    Report Number
    3006389770-2010-00002
    Event Type
    Malfunction
    Date Received
    March 16, 2010
    Date of Event
    January 10, 2010
    Report Date
    March 4, 2010
    Manufacturer
    MEDITEC DEVICES
    Product Code
    BSR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO PIECES OF LOT NO. MD 016 FROM OUR CONTROL SAMPLES CHOSEN RANDOMLY WAS SUBJECTED TO PHYSICAL PULLING BUT THESE DO NOT EXHIBIT ANY KIND OF BREAKAGE. FOUR PIECES OF LOT MD 016 AND 4 PIECES EACH FROM EXPIRED LOTS MD 002 AND MD 003 ARE SENT TO TENSILE TESTING LABORATORY. THESE RESULT OF THE TESTS ARE AWAITED. THE EXPIRED LOTS [THREE YEARS FROM THE DATE OF MANUFACTURER] WILL ALSO INDICATE THE PHYSICAL STRENGTH AFTER THE EXPIRY PERIOD.

    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 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 THE PREVIOUS DAY) PIECE OF ENDOTRACHEAL TUBE INTRODUCER. THE ORIGINAL LENGTH OF THE INTRODUCER WAS 70 CMS. PT TOLERATED THE PROCEDURE WITHOUT DIFFICULTY.

    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