BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMITHS MEDICAL SILICONE BIVONA ADULT TRACHEOSTOMY TUBE

    MDR report key: 9327671 · Received November 15, 2019

    Report

    Report Number
    3012307300-2019-06336
    Event Type
    Malfunction
    Date Received
    November 15, 2019
    Report Date
    November 4, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    POTENTIAL LOTS INCLUDE: 3782520, 3831778, 3831779, 377445, 3782520. EIGHT TRACHEOSTOMY TUBES WERE RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE EIGHT CUFFS FOUND TINY SCRATCHES NEXT TO THE SMALL HOLES ON THE CUFFS, PERHAPS CAUSED BY THE DEVICE COMING INTO CONTACT WITH SOMETHING SHARP EXTERNALLY OR POTENTIALLY FROM HARD CARTILAGE INTERNAL TO THE PATIENT. THE DEVICES THEN UNDERWENT FUNCTIONAL TESTING; CUFFS WERE LEAK TESTED. CUFFS WERE UNABLE TO FULLY INFLATE, IMMEDIATELY DEFLATING AS AIR ESCAPED FROM A SMALL HOLE. THE HOLES AND SCRATCHES ALIGN IN THE SAME LOCATIONS ON THE CUFFS WITH ALL EIGHT SAMPLES. THIS INVESTIGATION HAS CONFIRMED THE REPORTED CUSTOMER COMPLAINT. WHILE NO DEFINITIVE PROBLEM SOURCE TO THE REPORTED ISSUE COULD BE DETERMINED, THIS INVESTIGATION REVEALED NO INTRINSIC EVIDENCE TO SUGGEST A CAUSE OF ISSUE RELATED TO MANUFACTURING.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT WHILE A SMITHS MEDICAL TRACHEOSTOMY WAS IN USE, THE CUFF WAS NOTED TO HAVE A PINHOLE LEAK. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124037 SMITHS MEDICAL SILICONE BIVONA ADULT TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR