BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    MDR report key: 1853834 · Received September 8, 2010

    Report

    Report Number
    2936999-2010-01172
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 10, 2010
    Manufacturer
    COVIDIEN/ FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HISTORY RECORD FOR THE LOT NUMBER PROVIDED WILL BE REVIEWED. IF THE SAMPLE IS RETURNED, A FAILURE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    THE CALLER REPORTED THAT THE TUBE WAS PLACED IN THE PT ON THE (B)(6) 2010. AROUND THE BEGINNING OF (B)(6), THE PT STATED THAT THIS TUBE WAS CAUSING HIM PAIN, AND REQUESTED A REPLACEMENT TUBE. THE TUBE WAS NOT ABLE TO BE REPLACED BEFORE THE SCHEDULED REPLACEMENT DAY. THE TUBE WAS REMOVED FROM THE PT, AND REPLACED WITH A NEW TUBE, ACCORDING TO SCHEDULE ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA LOW PRESSURE TRACHEOSTOMY TUBE JOH COVIDIEN/ FORMERLY TYCO HEALTHCARE 1003000858

    Patients

    Seq Age Sex Outcome Treatment
    1