BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    MDR report key: 2000719 · Received February 16, 2011

    Report

    Report Number
    2936999-2011-00120
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 11, 2011
    Manufacturer
    COVIDIEN / FORMERLY TYCO
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE LOT NUMBER PROVIDED WILL BE REVIEWED. IF THE SAMPLE IS RETURNED A FAILURE INVESTIGATION WILL BE PERFORMED. IF SIGNIFICANT INFORMATION IS OBTAINED 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 THAT THE TRACHEOSTOMY TUBE WAS PUT IN THE PATIENT ON (B)(6) 2011 AND WAS PRETESTED. TWO TO THREE HOURS AFTER THE IT WAS PLACED IN THE PATIENT THEY HEARD THE VENTILATOR ALARM, AND NOTICED THAT THE TUBE WAS NOT HOLDING AIR. NO PATIENT HARM WAS NOTED AND THE TUBE WAS REMOVED, AND REPLACED WITH A NEW 10DCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA LOW PRESSURE TRACHEOSTOMY TUBE JOH COVIDIEN / FORMERLY TYCO 1012000676

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention