BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY PEDIATRIC

    MDR report key: 2113761 · Received June 2, 2011

    Report

    Report Number
    2936999-2011-00327
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 9, 2011
    Manufacturer
    COVIDIEN/FORMERLY TYCO
    Product Code
    JOH
    PMA / PMN Number
    K945513
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 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 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 CUSTOMER STATED THAT DURING A ROUTINE TRACHEOSTOMY TUBE CHANGE, THEY WERE UNABLE TO INSERT THE TUBE WITH SEVERAL ATTEMPTS. THEY DISCOVERED THE 5.0 PED TO HAVE A 7.1MM OD, AND A 7.5MM OD TOWARDS THE DISTAL END OF THE TUBE. THE DISTAL END LOOKED FLARED OUT. THE PATIENT WAS RE CANNULATED WITH A SMALLER TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY PEDIATRIC TRACHEOSTOMY TUBE JOH COVIDIEN/FORMERLY TYCO 1010000848

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention