BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER CANNULA

    MDR report key: 9558973 · Received January 6, 2020

    Report

    Report Number
    MW5092058
    Event Type
    Malfunction
    Date Received
    January 6, 2020
    Date of Event
    January 2, 2020
    Report Date
    January 3, 2020
    Manufacturer
    MEDPLAST / VIANT MEDICAL, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    WE RECEIVED 4 BOXES OF 10 EACH PHONERIS INNER CANNULAE, REF (B)(4) FROM OUR SON'S RESPIRATORY EQUIPMENT SUPPLIER, (B)(4), 17 OF THE 40 CANNULAE WERE MISBOXED WITH A LARGER SIZE CANNULA PUT INTO A SEALED AND MARKED SMALLER CONTAINER, FROM LOT 35385029. FORTUNATELY WE CAUGHT THE MISBOXED PRODUCT BEFORE TRYING TO INSERT IT INTO OUR SON'S SHILEY 6DFEN TRACHEOSTOMY TUBE AND HAD BACK-UP CORRECT PRODUCT ON HAND TO USE. WE HAVE 2 SONS ON VENTILATORS FOR THE PAST 9 YEARS AND ARE VERY FAMILIAR WITH HANDLING ANY UNFORESEEN PROBLEMS, BUT WORRY ABOUT FAMILIES / CAREGIVERS WITHOUT OUR EXPERIENCE WITH TRACHES SPENDING TOO MUCH TIME TRYING TO INSERT THE MISBOXED PRODUCTS AND ENDANGERING THEIR LOVED ONES FROM BEING OFF THE VENTILATOR ASSIST TOO LONG. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12502 INNER CANNULA TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR BTO MEDPLAST / VIANT MEDICAL, INC.
    12505 INNER CANNULA TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR BTO MEDPLAST / VIANT MEDICAL, INC. HCSTIC6A 35385029
    12506 INNER CANNULA TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR BTO MEDPLAST / VIANT MEDICAL, INC.
    12507 INNER CANNULA TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR BTO MEDPLAST / VIANT MEDICAL, INC.
    12508 INNER CANNULA TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR BTO MEDPLAST / VIANT MEDICAL, INC.
    12509 INNER CANNULA TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR BTO MEDPLAST / VIANT MEDICAL, INC.
    12510 INNER CANNULA TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR BTO MEDPLAST / VIANT MEDICAL, INC.
    12511 INNER CANNULA TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR BTO MEDPLAST / VIANT MEDICAL, INC.
    12512 INNER CANNULA TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR BTO MEDPLAST / VIANT MEDICAL, INC.
    12513 INNER CANNULA TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR BTO MEDPLAST / VIANT MEDICAL, INC.
    12514 INNER CANNULA TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR BTO MEDPLAST / VIANT MEDICAL, INC.
    12515 INNER CANNULA TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR BTO MEDPLAST / VIANT MEDICAL, INC.
    12516 INNER CANNULA TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR BTO MEDPLAST / VIANT MEDICAL, INC.
    12517 INNER CANNULA TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR BTO MEDPLAST / VIANT MEDICAL, INC.
    12518 INNER CANNULA TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR BTO MEDPLAST / VIANT MEDICAL, INC.
    12519 INNER CANNULA TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR BTO MEDPLAST / VIANT MEDICAL, INC.
    12520 INNER CANNULA TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR BTO MEDPLAST / VIANT MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR