BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    MDR report key: 2210340 · Received August 8, 2011

    Report

    Report Number
    2936999-2011-00521
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 12, 2011
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    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

    DURING THE MANUFACTURERS INVESTIGATION OF THE RETURNED 6DCT WITH LOT NUMBER 1102001295 AN INFLATION/DEFLATION TEST WAS PERFORMED INSERTING 14 CC OF AIR WITH A SYRINGE AND THE CUFF MAINTAINED IT'S AIR PRESSURE. THE SAMPLE WAS THEN SUBMERGED INTO A CONTAINER WITH WATER REPEATING INFLATION STEPS AND NO LEAK WAS OBSERVED IN THE BODY OF THE CUFF, FLAT PILOT BALLOON / (SEAM) OR THE INFLATION LINE TUBING. THE REPORTED FAILURE MODE WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    THE CALLER REPORTED THEY HAD A 6DCT WHICH DID NOT HOLD AIR. THE SPOT OF THE LEAK WAS NOT ISOLATED. THE TRACH WAS INSTALLED ON (B)(6) 2011 AND THE PATIENT REQUIRED RECANNULATION WITH ANOTHER 6DCT (B)(6) 2011. THE CALLER REPORTED THAT THEY PRE-TEST THE CUFF TESTED AND INFLATE USING MIN LEAK TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA LOW PRESSURE TRACHEOSTOMY TUBE JOH COVIDIEN/FORMERLY TYCO HEALTHCARE 1102001295

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention