BEUDAMED
    FDA Adverse Event Summary report: N

    REINFORCED TRACHEAL TUBE

    MDR report key: 2024302 · Received March 3, 2011

    Report

    Report Number
    2024302
    Date Received
    March 3, 2011
    Date of Event
    February 11, 2011
    Report Date
    March 3, 2011
    Manufacturer
    COVIDIEN NELLCOR MALLINCKRODT
    Product Code
    BTR
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INTUBATED ICU PATIENT, S/P STATUS POST CRANIOTOMY, WAS BROUGHT TO MRI. SIGNIFICANT ARTIFACT WAS NOTED ON MRI EXAM. IT WAS SUBSEQUENTLY NOTED THAT THE ETT CONTAINED A METAL REINFORCEMENT COIL WHICH INTERFERED WITH THE MRI. THE PRODUCT PACKAGING AND DEVICE DO NOT INDICATE THAT THE TRACHEAL TUBE CONTAINS METAL AND IS NOT SAFE FOR MRI SCANNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REINFORCED TRACHEAL TUBE ENDOTRACHEAL TUBE BTR COVIDIEN NELLCOR MALLINCKRODT CUFFED 2001-03 4934

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR