BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    MDR report key: 2113384 · Received May 26, 2011

    Report

    Report Number
    2936999-2011-00356
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 2, 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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK; THEREFORE, THE DATE OF MFR CANNOT BE DETERMINED. THE SAMPLE ASSOCIATED TO THIS REPORT IS CURRENTLY IN TRANSIT TO THE MFG SITE FOR INVESTIGATION. 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 FAILED WITHIN 15 MINUTES AND THAT IT WOULD NOT STAY INFLATED. THE CALLER STATED THAT THE TRACHEOSTOMY TUBE WAS PRE-TESTED, AND THAT THE PT TOLERATED THE TUBE CHANGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention