BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY PERCUTANEOUS

    MDR report key: 1132583 · Received August 22, 2008

    Report

    Report Number
    2936999-2008-00409
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 7, 2008
    Manufacturer
    COVIDIEN/ FORMERLY TYCO HEALTHCARE
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ANALYSIS OR CONCLUSIONS CAN BE DRAWN WITHOUT THE DEVICE. RETURN OF THE SIZE 6 PERCUTANEOUS TRACHEOSTOMY TUBE FOR FAILURE INVESTIGATION HAS BEEN REQUESTED. THE LOT NUMBER WAS PROVIDED AND THE MFR WILL REVIEW THE LOT HISTORY RECORDS. IF THE TUBE IS RETURNED AND FAILURE INVESTIGATION RESULTS PROVIDE NEW OR SIGNIFICANT INFO, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CALLER REPORTED HAVING AN ISSUE WITH THE SHILEY SIZE 6 PERCUTANEOUS TRACHEOSTOMY TUBE. THE RPTR STATED THAT IN PREPARING TO INSERT THE TRACHEOSTOMY TUBE, THE RESIDENT WAS CAREFUL TO EXAMINE BOTH THE CUFF AND THE DISTAL TIP AND BOTH WERE OK. DURING THE INSERTION, SHE FELT AN OBSTRUCTION AND THE TUBE COULD NOT BE ADVANCED. THE ATTENDING PHYSICIAN TOOK OVER AND REMOVED THE TUBE SO THAT THEY COULD OXYGENATE THE PT. AT THAT TIME, THEY CHECKED THE CUFF AND DISTAL TIP AGAIN FOUND THAT THE TIP OF THE TUBE WAS NOW MISSHAPED. IT HAD BEEN FLATTENED AND WAS ALMOST AN OVAL SHAPE. THE MISSHAPING CREATED AN OBSTRUCTION AND THE DILATORS COULD NOT BE PASSED THROUGH THE TUBE. ANOTHER 6 PERCUTANEOUS TUBE WAS INSERTED WITHOUT ISSUE. THE PT DID NOT HAVE AN UNUSUAL ANATOMY. THERE WAS NO UNUSUAL PRESSURE OR TORQUE APPLIED TO THE INITIAL TRACHEOSTOMY TUBE DURING INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY PERCUTANEOUS TRACHEOSTOMY TUBE BTO COVIDIEN/ FORMERLY TYCO HEALTHCARE 0805002358

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention