BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRODUCER (BOUGIE)

    MDR report key: 1637599 · Received March 16, 2010

    Report

    Report Number
    3006389770-2010-00001
    Event Type
    Malfunction
    Date Received
    March 16, 2010
    Date of Event
    January 10, 2010
    Report Date
    February 18, 2010
    Manufacturer
    MEDITEC DEVICES
    Product Code
    BSR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE RECEIVED THE SAMPLE SENT TO US. THE COVER CONTAINED THREE PIECES OF TUBING EACH LENGTHS 1/2" APPROX AND MANY SMALLER PIECES SUPPOSEDLY BROKEN/ FRAGMENTED FROM SIMILAR PIECES OF TUBES. ONE SMALL FRAGMENT CONTAINED A SMALL BLACK VERTICAL MARK AND 3/4TH OF THE LETTER 3 AND 1/2 OF THE LETTER 0, THEN ANOTHER PIECE CONTAINED PRESUMABLY THE OTHER HALF OF THE LETTER 0 AND YET ANOTHER PIECE CONTAINED A 2.5MM LONG AND 1.20MM THICK LINE SUPPOSEDLY THE MARK ALONG THE AXIS OF THE TUBE THAT APPEARS IN BETWEEN THE MARKINGS 20 AND 30 ON THE ET INTRODUCER. PRELIMINARY ASSESSMENT INDICATES THAT THIS FONT SIZES HAVE NEVER BEEN USED BY US AND THE ABOVE MENTIONED 1.20MM THICK LINE ALONG THE AXIS IN OUR MANUFACTURE IS HAVING A THICKNESS OF LESS THAN 0.50MM. WE HAVE COMPARED THIS WITH THE CONTROL SAMPLES OF ALL BATCHES THAT WE HAVE EVER MANUFACTURED, BUT ARE UNABLE TO ASSIGN THE BROKEN SAMPLE RECEIVED TO ANY OF OUR BATCHES. FURTHER, THE THREE PIECES OF TUBING MENTIONED ABOVE, WE TRIED TO BREAK ONE PIECE WITH A SMALL STEEL ROD AND THIS PIECE OF TUBING SIMPLY CRACKED UP INTO MANY SMALL PIECES LIKE BREAKING GLASS. THIS SAYS THAT THE MATERIAL IS VERY BRITTLE. WE COULD MAKE THIS BRITTLENESS OUT BY FEELING THE PIECES AND THE TEST WITH THE HAMMER PROVES IT. THE MATERIAL WE USE FOR THE MANUFACTURE OF THE INTRODUCER IS POLYETHYLENE AND THIS WILL GET CRUSHED BUT NEVER CRACK UP INTO PIECES/FRAGMENTS. SO WE RAN THIS HAMMER TEST ON 2 PIECES FROM ALL BATCHES FROM MD002 [EXPIRED] TO MD018 FROM OUR CONTROL SAMPLES, ALL THE TUBES ONLY GET SLIGHTLY DEFORMED DUE TO THE HAMMER BLOW BUT NONE SHOWED ANY BRITTLENESS AS EXHIBITED BY THE BROKEN SAMPLE RECEIVED. IT APPEARS TO BE A DIFFERENT PLASTIC. WE WILL RUN A POLYMER IDENTIFICATION TEST AND REPORT AS SOON AS IT IS CONDUCTED IN AN OUTSIDE LAB.

    Description of Event or Problem · 1

    ENDOTRACHEAL TUBE INTRODUCER WAS USED TO EXCHANGE THE ENDOTRACHEAL TUBE THAT WAS PLACED IN THE PT'S TRACHEA. PT'S AIRWAY WAS DIFFICULT. ONCE PLACED IN THE ENDOTRACHEAL TUBE, THE INTRODUCER BROKE INTO TWO PIECES. ALL CONTENTS OF THE BLUE ENDOTRACHEAL TUBE WERE REMOVED WITH THE ENDOTRACHEAL TUBE UNDER DIRECT LARYNGOSCOPE. ANOTHER BLUE ENDOTRACHEAL TUBE WAS USED WITHOUT DIFFICULTY TO PLACE A NEW ENDOTRACHEAL TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRODUCER (BOUGIE) ENDOTRACHEAL TUBE INTRODUCER BSR MEDITEC DEVICES 9-0212-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR