BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 3853015 · Received May 23, 2014

    Report

    Report Number
    2936999-2014-00452
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 19, 2014
    Report Date
    April 25, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    PMA / PMN Number
    K871204
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE ASSOCIATED TO THIS REPORT IS EXPECTED TO BE RETURNED FOR ANALYSIS. IF THE SAMPLE IS RECEIVED, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS PERFORMED ON ONE RETURNED SAMPLE OF A MALLINCKRODT HI-LO ENDOTRACHEAL TUBE RECEIVED FOR EVALUATION, AND NO LOT NUMBER WAS PROVIDED. INFLATION/DEFLATION TESTS WERE PERFORMED BY USING A 25 CC SYRINGE OF AIR APPLIED TO THE CUFF, AND IT WAS OBSERVED THAT IT DEFLATED IMMEDIATELY. A VISUAL INSPECTION WAS PERFORMED AND IT WAS OBSERVED THAT THE CUFF EXHIBITED A CUT MEASURING 0.7520 INCHES. THE CUSTOMER REPORTED FAILURE MODE OF A CUT IN CUFF WAS CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATES: 3 DAYS AFTER INTUBATION, AIR LEAKED FROM THE CUFF. THE CUSTOMER COULD NOT CONFIRM IF THE TUBE WAS PRETESTED. THE CUSTOMER DID CONFIRM THAT REPLACEMENT OF THE TUBE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309123 MALLINCKRODT 7.0 HI-LO TRACHEAL TUBE BTR COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention