BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY PEDIATRIC CUFFED

    MDR report key: 2010483 · Received March 1, 2011

    Report

    Report Number
    2936999-2011-00095
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 2, 2011
    Manufacturer
    COVIDIEN/ FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K955680
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    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. IF RETURNED, A FAILURE INVESTIGATION WILL BE PERFORMED. IF SIGNIFICANT INFO IS OBTAINED FROM INVESTIGATION, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER 2 TO 3 HRS OF USE, THE CUFF LOST AIR. THE PT REQUIRED A NON-ROUTINE RE-CANNULATION OF THE TRACHEOSTOMY TUBE. THE CUSTOMER REPORTED THAT THE CUFF WAS PRE-TESTED PRIOR TO INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY PEDIATRIC CUFFED TRACHEOSTOMY TUBE JOH COVIDIEN/ FORMERLY TYCO HEALTHCARE 1003000803

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention