BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY PERCUTANEOUS

    MDR report key: 1201494 · Received October 17, 2008

    Report

    Report Number
    2936999-2008-00459
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 17, 2008
    Manufacturer
    COVDIEN/FORMERLY TYCO HE
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ANALYSIS OR CONCLUSIONS CAN BE DRAWN WITHOUT THE DEVICE OR THE LOT NUMBER. RETURN OF THE PERCUTANEOUS TRACHEOSTOMY TUBE FOR FAILURE INVESTIGATION HAS BEEN REQUESTED. IF THE TUBE IS RETURNED AND FAILURE INVESTIGATION RESULTS PROVIDE NEW OR SIGNIFICANT INFO, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CALLER REPORTED THAT PRIOR TO PERFORMING THE TRACHEOSTOMY PROCEDURE, THE TUBE WAS INSPECTED AND NO ABNORMALITIES WERE OBSERVED. THE TUBE WAS LUBRICATED USING A WATER SOLUBLE STERILE LUBRICATING JELLY. THIS IS THE SAME SURGICAL LUBRICANT THAT THEY HAVE USED FOR SEVERAL YEARS. AFTER ROUTINE PREP OF THE AREA, THE DR ATTEMPTED TO INSERT AND ADVANCE THE TUBE INTO THE TRACHEA, BUT WAS NOT ABLE. THE CALLER REPORTED THE DR FELT THAT THERE WAS AN OBSTRUCTION THAT WAS PROBABLY CREATED BY ONE OF THE CARTILAGE RINGS THAT PREVENTED THE INSERTION. THE TUBE WAS REMOVED AND ANOTHER TUBE WAS INSERTED WITHOUT ISSUE. THE ORIGINAL TUBE WAS EXAMINED AND THE DR NOTED WHAT APPEARED TO BE A MALFORMATION CONSISTING OF A CRIMP AND A FLARING OUT OF THE DISTAL TIP ON THE ANTERIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY PERCUTANEOUS TRACHEOSTOMY TUBE BTO COVDIEN/FORMERLY TYCO HE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention