BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY PEDIATRIC SPECIALIZED

    MDR report key: 1940446 · Received December 20, 2010

    Report

    Report Number
    2936999-2010-01390
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 29, 2010
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    CBI
    PMA / PMN Number
    K925615
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HISTORY RECORD FOR THE LOT NUMBER PROVIDED WILL BE REVIEWED. IF THE SAMPLE IS RETURNED, A FAILURE INVESTIGATION WILL BE PERFORMED. IF SIGNIFICANT INFO IS OBTAINED FROM THE INVESTIGATION, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CALLER REPORTED THAT THE TRACHEOSTOMY TUBE DOES NOT HAVE A CUFF ON IT AS ORDERED. THE CALLER STATED THAT THE TUBE WAS PLACED IN THE PT BEFORE THEY NOTICED IT HAD NO CUFF. THE TUBE WAS REMOVED, AND THE PT WAS RE CANNULATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY PEDIATRIC SPECIALIZED TRACHEOSTOMY TUBE CBI COVIDIEN/FORMERLY TYCO HEALTHCARE 1011001547

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention