BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    MDR report key: 1821494 · Received August 25, 2010

    Report

    Report Number
    2936999-2010-01055
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    July 31, 2010
    Report Date
    August 5, 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
    CA
    Reporter Occupation
    OTHER

    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 COVIDIEN REPRESENTATIVE IN (B)(4) RECEIVED A REPORT FROM A RESPIRATORY THERAPIST THAT A PERCUTANEOUS TRACHEOSTOMY WAS PERFORMED ON THE PATIENT AROUND NOON, USING A DISPOSABLE CANNULA WHICH WAS DIFFICULT TO PUT IN AND A LOT OF FORCE WAS NEEDED TO PUSH THROUGH THE CARTILAGE. THE THERAPIST STATED IT LOOKED A LITTLE ODD BUT SHE COULDN'T QUITE PLACE WHAT WAS EXACTLY WRONG. LATER BY 6PM WHEN THE RESPIRATORY THERAPIST WAS PERFORMING TRACHEOSTOMY CARE ON THE PATIENT, THE FLANGE CAME OFF THE TUBE AND THE PATIENT COUGHED, EJECTING THE TUBE OUT OF THE STOMA. THE FLANGE REMAINED AROUND THE PATIENT'S NECK. THEY IMMEDIATELY REINSERTED THE SAME TUBE. THE RESPIRATORY THERAPISTS STATED IT TOOK HERSELF, AND TWO OTHERS WITH HEMOSTATS AND A LOT OF FORCE TO TRY AND GET THE "LUMEN" BACK INTO PLACE AND THE PINS OF THE "LUMEN" INTO THE GROOVES OF THE FLANGE, RESULTING IN A LOT OF BLOOD AND TRAUMA. THE THERAPIST AND A NURSE THEN REMOVED THE TUBE AND RE-CANNULATED THE PATIENT WITH ANOTHER 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 1001001106

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention