BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-LO

    MDR report key: 2140678 · Received June 13, 2011

    Report

    Report Number
    2140678
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    COVIDIEN NELLCOR MALLINCKRODT
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    THERE WAS NO EVENT; THIS WAS A POTENTIAL HAZARD IDENTIFIED BY A TEAM MEMBER AND BROUGHT TO MY ATTENTION. THE LABELING ON THE PRODUCT HAS CHANGED RECENTLY AND POSES A POTENTIAL RISK TO OUR PATIENTS. THE LABELING OF COVIDIEN/MALLINCRODT CUFFED TRACHEAL TUBE SIZES USED TO BE VERY PROMINENT ON THE PACKAGE, DECREASING THE LIKELIHOOD OF A TEAM MEMBER SELECTING THE INCORRECT SIZE. THE NEW PACKAGING HAS MUCH SMALLER LETTERING USED TO INDICATE THE TUBE SIZE AND HAS THE POTENTIAL TO INCREASE HUMAN ERROR DURING SELECTION OF SIZES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-LO TRACHEAL TUBE BTR COVIDIEN NELLCOR MALLINCKRODT * 110201095X

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention