BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY CUFFED PEDIATRIC

    MDR report key: 2113766 · Received June 2, 2011

    Report

    Report Number
    2936999-2011-00366
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    March 20, 2011
    Report Date
    May 11, 2011
    Manufacturer
    COVIDIEN/FORMERLY TYCO
    Product Code
    JOH
    PMA / PMN Number
    K945513
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE LOT NUMBER PROVIDED WILL BE REVIEWED. RETURN OF THE TRACHEOSTOMY TUBE FOR INVESTIGATION WAS REQUESTED BUT HAS NOT BEEN RETURNED TO DATE. IF RETURNED, A FAILURE INVESTIGATION WILL BE PERFORMED. IF SIGNIFICANT INFORMATION IS IDENTIFIED FROM THE INVESTIGATION, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE COVIDIEN REPRESENTATIVE IN (B)(6) RECEIVED A REPORT THAT THE CUFF OF A PATIENT'S TRACHEOSTOMY TUBE WAS LEAKING. THEY IDENTIFIED A RUPTURE IN THE CUFF. THE PRODUCT WAS USED FOR 18 DAYS AND RE CANNULATION OF THE PATIENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE JOH COVIDIEN/FORMERLY TYCO 1005000693

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention