BEUDAMED
    FDA Adverse Event Other Summary report: N

    MALLINCKRODT

    MDR report key: 1912814 · Received November 5, 2010

    Report

    Report Number
    2936999-2010-01308
    Event Type
    Other
    Date Received
    November 5, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 7, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ASSOCIATED TO THIS REPORT LATER CONFIRMED THAT MEDICAL INTERVENTION WAS NOT REQUIRED. IT WAS CONFIRMED THAT THE MARKINGS ON THE TUBE INCORRECTLY ASSESSED BY THE END USER. THIS REPORT WILL BE MONITORED AS A HUMAN FACTOR USABILITY ISSUE HOWEVER; INFO HAS BEEN ADDED TO THE DATABASE AND TRENDS WILL CONTINUE TO BE MONITORED. PART NUMBER# 127-45-2 IS NOT DISTRIBUTED IN THE U.S.; HOWEVER, IS A DEVICE OF ESSENTIALLY IDENTICAL DESIGN DISTRIBUTED IN THE U.S. APPLICABLE 510K# FOR U.S. DISTRIBUTED PART IS K841872.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED A REPORT WHERE IT WAS CLAIMED THAT THE TUBE WAS PLACED IN A PT'S AIRWAY. THE CALLER REPORTED THAT THE MARKINGS ON THE TUBE WERE INCORRECTLY READ AND THOUGHT TO BE DEPTH MARKERS AND USED AS A GUIDE TO TRACHEAL PLACEMENT. THE MARKINGS WERE ACTUALLY THE INTERNAL DIAMETER AND OUTER DIAMETER MEASUREMENTS PRINTED ON THE TUBE. THE ERROR WAS NOTICED IMMEDIATELY WHEN THE TUBE LENGTH WAS RE-ASSESSED AT THE LIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT 4.5MM SAFETY FLEX PVC UNCUFF X10 BTR COVIDIEN, FORMERLY TYCO HEALTHCARE 2010017877

    Patients

    Seq Age Sex Outcome Treatment
    1