BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUFFED BLUE LINE ULTRA TRACHEOSTOMY TUBE

    MDR report key: 7664832 · Received July 5, 2018

    Report

    Report Number
    3012307300-2018-02677
    Event Type
    Malfunction
    Date Received
    July 5, 2018
    Date of Event
    June 12, 2018
    Report Date
    October 2, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING DECONTAMINATED SAMPLES WERE RECEIVED IN PLASTIC BAG WITHOUT ITS ORIGINAL PACKAGING: 1 X007/910/685 BLU TRACHEOSTOMY TUBE 8.5MM S/ASSY 1/EA. 2 X 005/073/685 8.5MM BLU THIN WALL INNER CANNWITH STOP RING. UNDER VISUAL INSPECTION THE TECHNICIAN NOTICED THAT ONE INNER CANNULA WAS DAMAGED - THERE ARE THREE CRACKS APP. 4CM LONG (MEASURED BY RULER G:00626-CZ, CALIBRATION TILL (B)(6)2021), TWO CRACKS IN SPLIT LINE AND ONE ON SIDE. THE SECOND CANNULA AND TRACHEOSTOMY TUBE WERE FOUND TO BE WITH NO DEFECT. THE CUSTOMER'S REPORTED ISSUE COULD NOT BE DUPLICATED WITH 20 INNER CANNULAS FROM PRODUCTION. BASED ON THE RESULTS OF THE INVESTIGATION IT IS MOST PROBABLE THAT THE FAILURE IS A RESULT OF THE CUSTOMER/ USER INTERFACING WITH THE PRODUCT IN A MANNER INCONSISTENT WITH THE IFU.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT THE PORTEX TRACHEOSTOMY TUBE HAD CRACK DURING PLACEMENT. NO REPORTED ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506832 CUFFED BLUE LINE ULTRA TRACHEOSTOMY TUBE TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL ASD, INC. 3395516

    Patients

    Seq Age Sex Outcome Treatment
    1