BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    MDR report key: 1884926 · Received October 21, 2010

    Report

    Report Number
    2936999-2010-01226
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 24, 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
    MS, 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 A RESPIRATORY THERAPIST WAS TURNING THE PATIENT AND NOTICED THE FLANGE OF THE TRACHEOSTOMY TUBE HAD BROKEN WHERE IT CONNECTS TO THE COLLAR. THIS REQUIRED PATIENT RECANNULATION WITH ANOTHER 8DCT. THERE WERE NO COMPLICATIONS. THE CALLER DID NOT KNOW HOW LONG THE TRACHEOSTOMY TUBE HAD BEEN IN USE, OR IF THE PATIENT IS ON A VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA LOW PRESSURE TRACHEOSTOMY TUBE JOH COVIDIEN/FORMERLY TYCO HEALTHCARE 0912001612

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention