BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    MDR report key: 1852461 · Received September 29, 2010

    Report

    Report Number
    2936999-2010-01167
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 2, 2010
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 PILOT BALLOON FAILED ON THIS 8DCT TRACHEOSTOMY TUBE 9 DAYS AFTER IT WAS PLACED IN THE PATIENT. IT HAD BEEN TESTED PRIOR TO INSERTION. THE PATIENT REQUIRED A NON-ROUTINE REPLACEMENT (RE CANNULATION) OF THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA LOW PRESSURE TRACHEOSTOMY TUBE JOH COVIDIEN/FORMERLY TYCO HEALTHCARE 1003000051

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention