BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE LINE ULTRA TRACHEOSTOMY TUBE

    MDR report key: 3862989 · Received June 4, 2014

    Report

    Report Number
    2183502-2014-00373
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    May 5, 2014
    Report Date
    June 3, 2014
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD.
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR COMPLETED THE ENTIRE FORM. ADDITIONAL MFR NARRATIVE: CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION. (B)(4).

    Description of Event or Problem · 1

    USER FACILITY REPORTED THE DEVICE WAS IN USE WITH A PT; AFTER THE PT WAS ROTATED (REASON NOT PROVIDED), THE PT WAS UNABLE TO BREATHE. USER FACILITY OBSERVED THE VENTILATOR DROPPING TO 0. THE PT WAS ROTATED BACK TO THE ORIGINAL POSITION AND STILL COULD NOT BREATHE. USER FACILITY ATTEMPTED TO DEFLATE THE CUFF AND SUCTION THE TRACHEOSTOMY TUBE, BUT AN OBSTRUCTION AT THE END OF THE TUBE PREVENTING SUCTIONING. THE PT WAS VENTILATED BY HAND, BUT OXYGEN SATURATION LEVELS REMAINED LOW. THE PT WAS IMMEDIATELY ORALLY INTUBATED WHILE THE TRACHEOSTOMY TUBE WAS REPLACED. FOLLOWING THE EVENT, THE ENT DOCTOR VISUALIZED THE PT'S TRACHEA VIA BRONCHOSCOPY AND FOUND DAMAGE TO THE PT'S TRACHEAL MUCOSA DUE TO CONTACT WITH THE TUBE. NO PERMANENT ADVERSE EFFECTS TO PT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326212 BLUE LINE ULTRA TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE BTO SMITHS MEDICAL INTERNATIONAL LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention