BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    MDR report key: 2013348 · Received March 8, 2011

    Report

    Report Number
    2936999-2011-00160
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    November 1, 2011
    Report Date
    February 8, 2011
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE LOT NUMBER PROVIDED WILL BE REVIEWED. A FAILURE INVESTIGATION WILL BE PERFORMED ON THE RETURNED SAMPLE. IF SIGNIFICANT INFORMATION IS OBTAINED FROM THE INVESTIGATION, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THIS REPORT IS THE SECOND OF FIVE TUBES REPORTED BY THE CUSTOMER ON (B)(6) 2011.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BULB ON FIVE 6DCT TRACHEOSTOMY TUBES DID NOT INFLATE EVENLY, RESULTING IN A MISSHAPEN BULB. THE CUSTOMER REPORTED THE PROBLEM STARTED WITHIN THE LAST FEW MONTHS AND THAT THEY WERE CHANGING OUT THE TRACHEOSTOMY TUBES WEEKLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA LOW PRESSURE TRACHEOSTOMY TUBE JOH COVIDIEN/FORMERLY TYCO HEALTHCARE 1006000354

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention