BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    MDR report key: 2030534 · Received March 18, 2011

    Report

    Report Number
    2936999-2011-00206
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 21, 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
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER PROVIDED WAS FOUND TO BE INVALID AND THEREFORE THE DATE OF MFR CAN NOT BE DETERMINED. IF SIGNIFICANT INFO 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 CALLER STATED THE TUBE SEPARATED FROM THE FLANGE, WHICH CAUSED THE PT TO COUGH OUT THE TRACHEOSTOMY TUBE. THIS REQUIRED RECANNULATION WITH ANOTHER 8DCT. THE CALLER DID NOT KNOW HOW LONG THIS TRACH WAS IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA LOW PRESSURE TRACHEOSTOMY TUBE JOH COVIDIEN FORMERLY/ TYCO HEALTHCARE 1089002097

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention