BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    MDR report key: 2153410 · Received June 29, 2011

    Report

    Report Number
    2936999-2011-00443
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 3, 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
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK THEREFORE, THE DATE OF MFR CANNOT BE DETERMINED. IF THE SAMPLE IS RETURNED, A FAILURE INVESTIGATION WILL BE PERFORMED. IF SIGNIFICANT INFO IS OBTAINED FROM THE INVESTIGATION, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE CALLER STATED 3 PATIENTS WERE INTUBATED YESTERDAY WITH TRACHEOSTOMY TUBES AND THEY DID NOT HOLD AIR. THE CALLER HAD LIMITED INFO AND DID NOT KNOW IF THEY WERE PRETESTED. THIS HAPPENED ALL IN THE SAME DAY DURING A ROUTINE TRACH CHANGE. THEY THINK IT IS THE PILOT BALLOON, BUT ARE NOT SURE.

    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