BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY PEDIATRIC

    MDR report key: 2040955 · Received March 25, 2011

    Report

    Report Number
    2936999-2011-00226
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 2, 2011
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEATHCARE
    Product Code
    JOH
    PMA / PMN Number
    K945513
    Removal / Correction Number
    Z-0997-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CALLER REPORTED THAT THE CUSTOMER WAS NOT ABLE TO PASS A SIZE 8FR SUCTION CATHETER INTO THE TRACHEOSTOMY TUBE. THE TRACHEOSTOMY TUBE WAS REMOVED AND DISCARDED AND THE PATIENT WAS RECANNULATED. THE TRACHEOSTOMY TUBE WAS IN PLACE FOR A COUPLE OF HOURS. NO HARM REPORTED OR ADDITIONAL TREATMENTS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY PEDIATRIC TRACHEOSTOMY TUBE JOH COVIDIEN/FORMERLY TYCO HEATHCARE 0808000387

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention