BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    MDR report key: 2113430 · Received May 26, 2011

    Report

    Report Number
    2936999-2011-00359
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 4, 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
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE LOT NUMBER PROVIDED WILL BE REVIEWED. RETURN OF THE TUBE FOR INVESTIGATION HAS BEEN REQUESTED. IF THE SAMPLE IS RETURNED, A FAILURE INVESTIGATION WILL BE PERFORMED. IF SIGNIFICANT INFO IS IDENTIFIED FROM THE INVESTIGATION, A SUMMARY OF THE FINDINGS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CALLER REPORTED THAT THE TRACHEOSTOMY TUBE'S CUFF FAILED TO INFLATE PROPERLY AFTER INSERTION. THE PT WAS REINTUBATED. THE CALLER WAS PRETTY SURE THE TRACH WAS IN LESS THAN 29 DAYS. THE CALLER WAS NOT SURE WHERE THE LEAK WAS OR IF THE CUFF WAS PRETESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA LOW PRESSURE TRACHEOSTOMY TUBE JOH COVIDIEN/FORMERLY TYCO HEALTHCARE 1008000270

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention