BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACHEOSTOMY PVC - PORTEX TUBES BLUE

    MDR report key: 15599321 · Received October 13, 2022

    Report

    Report Number
    3012307300-2022-23887
    Event Type
    Malfunction
    Date Received
    October 13, 2022
    Date of Event
    February 24, 2018
    Report Date
    October 13, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTO
    PMA / PMN Number
    K173384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    NO INFORMATION PROVIDED TO DATE. THIS MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS#: 617147. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. ONE SAMPLE OF 007/910/880 8MM BLU SUCTIONAID SUB-ASSY AND ONE SAMPLE OF 10008543-080 BLU OBTURATOR 8.0MM WERE RECEIVED IN PLASTIC BAG WITHOUT ITS ORIGINAL PACKAGING. UNDER VISUAL INSPECTION THE SAMPLE APPEARED TO BE IN GOOD CONDITION. THE SAMPLE WAS SUBMERGED IN WATER AND THE TRACHEOSTOMY TUBE CUFF WAS INFLATED USING A SYRINGE FILLED WITH AIR. AIR WAS OBSERVED TO BE LEAKING FROM APP. 0.1MM DIAMETER TEAR. DURING THE MANUFACTURING PROCESS THE TRACHEOSTOMY TUBES ARE 100% INFLATION TESTED, WHICH INCLUDES INFLATING EACH DEVICE CUFF AND LEAVING FOR A 12-HOUR PERIOD. REDUCTIONS IN PRESSURE OVER THIS TIME ARE CONSIDERED A FAILURE AND THE DEVICE WOULD BE REJECTED. THE INFLATION TEST WAS REPEATED ON THE RECEIVED SAMPLE. AFTER 12-HOUR PERIOD THE CUFF WAS SIGNIFICANTLY DEFLATED. CUFF TEAR WAS FOUND TO BE CAUSED BY "SPIDER LINE" AND CORRECTIVE ACTIONS HAVE BEEN PREVIOUSLY TAKEN. A TREND REVIEW WAS PERFORMED, AND ONE SIMILAR CUSTOMER COMPLAINT WAS FOUND. NO ACTION PLAN AT THIS TIME AS THIS OCCURRENCE WILL BE REGULARLY ANALYZED AND TRENDED FOR ANY FURTHER ACTIONS ACCORDINGLY. THE ROOT CAUSE OF THE REPORTED ISSUE IS A TEAR ON CUFF IS RESULT OF CUFF DEFECT CALLED "SPIDER LINE" WHICH IS AN ADDITIONAL LINE ON CUFF SURFACE SIMILAR TO A SPLIT LINE. THIS DEFECT MIGHT OCCUR WHEN MOLDING MACHINE IS OPERATING BELOW NOMINAL TEMPERATURE SETTINGS. THE SPIDER LINE MIGHT LEAD TO SMALL TEARS WHICH CAUSE CUFF LEAKS. ADDITIONALLY, THE ROOT CAUSE FOR FAILURE ESCAPE: ALL DEFECTIVE CUFFS WHICH ARE LEAKING SHALL BE DETECTED DURING EXECUTION OF INFLATION TEST. THE ROOT CAUSE FOR NON-DETECTION OF THIS INCIDENT REMAINS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PRE-TEST A CUFF LEAK WAS DISCOVERED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1781305 TRACHEOSTOMY PVC - PORTEX TUBES BLUE TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL ASD, INC. 3461578

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown