BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAM CANNULA

    MDR report key: 3625041 · Received January 31, 2014

    Report

    Report Number
    2025917-2014-00003
    Event Type
    Injury
    Date Received
    January 31, 2014
    Date of Event
    January 2, 2014
    Report Date
    January 2, 2014
    Manufacturer
    NEOTECH PRODUCTS, INC.
    Product Code
    CAT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY WAS UNABLE TO PROVIDE A WEIGH FOR THE PATIENT. NO LOT NUMBER WAS PROVIDED, THEREFORE A MANUFACTURE DATE COULD NOT BE DETERMINED. PHOTOGRAPHS WERE TAKEN OF THE RETURNED DEVICE. A VISUAL INSPECTION OF THE DEVICE WAS ALSO PERFORMED, REVEALING THAT THE DEVICE HAD BEEN CUT. THE USER FACILITY CONFIRMED THAT STAFF HAD CUT THE DEVICE IN ORDER TO "GET IT OFF THE PATIENT, AS THE NG TUBE WAS SECURED TO THE PATIENT'S FACE AND WE DID NOT WANT TO LOSE THE NG TUBE." THE VISUAL INSPECTION OF THE DEVICE ALSO REVEALED WHAT APPEARED TO BE A PEN OR INK MARKING NEAR THE PRONGS. THE USER FACILITY CONFIRMED THAT STAFF HAD DONE THIS, EXPLAINING THAT "WHEN THE RN/RT MARKS THE NUMBER ON THE NG TUBE FOR POSITION PLACEMENT, AFTER INSERTED, THE MARKER ALSO LEFT A MARK ON THE RAM." FURTHER EVALUATION IS CURRENTLY BEING CONDUCTED ON THE RETURN DEVICE IN AN ATTEMPT TO DETERMINE THE CAUSE OF THE PROBLEM. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE ADDITIONAL EVALUATION IS CONCLUDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE CANNULA TUBING KINKED APPROXIMATELY ONE INCH FROM THE CONNECTOR. THE KINKING WAS IDENTIFIED BY THE RESPIRATORY THERAPIST AS THE PATIENT HAD "AN INCREASED WOB, RETRACTIONS, INCREASED RESPIRATORY RATE AND STARTED TO DESAT." THE INTERVENTION PERFORMED WAS DESCRIBED AS, "BLOW BY GIVEN TO PATIENT VIA AN ANESTHESIA BAG WHILE THE RAM WAS TAKEN OFF PATIENT AND REPLACED TO MAINTAIN O2 SATS." AS OF THIS REPORT, THE PATIENT WAS STILL HOSPITALIZED AND IN STABLE CONDITION. THE DEVICE HAD BEEN IN USE "LESS THAN A WEEK" AT THE TIME OF THE INCIDENT. THE USER FACILITY STATES THAT THE "DIRECTIONS FOR USE" WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68347 RAM CANNULA NASAL OXYGEN CANNULA CAT NEOTECH PRODUCTS, INC. N4903

    Patients

    Seq Age Sex Outcome Treatment
    1 13 MO Required Intervention