BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOTECH RAM CANNULA

    MDR report key: 3716119 · Received March 22, 2014

    Report

    Report Number
    2025917-2014-00005
    Event Type
    Injury
    Date Received
    March 22, 2014
    Date of Event
    December 1, 2013
    Report Date
    February 19, 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 DEVICE INVOLVED IN THE COMPLAINT WAS NOT RETURNED TO THE MFR, AS IT WAS DISCARDED BY THE FACILITY. AS NO LOT NUMBER WAS PROVIDED, THE DATE OF MANUFACTURE COULD NOT BE DETERMINED. TESTING OF RETAINED SAMPLES REVEALED THAT THE COMPLAINT REGARDING THE CHANGE IN COLOR OF THE CANNULA PRONGS WAS CONFIRMED, HOWEVER THE TESTING COULD NOT CONFIRM A CHANGE IN SIZE. THIS IS FINAL REPORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM A HOSPITAL THAT "SOMETIME IN (B)(6) 2013" A RESPIRATORY THERAPIST NOTICED THAT THE CANNULA, WHICH HAD "BEEN ON A PATIENT WITH A HEATED CIRCUIT SET AT 37 DEGREES CELSIUS FOR APPROXIMATELY THREE DAYS" APPEARED TO HAVE CHANGED COLOR AND SHAPE, THE PRONGS GETTING "WIDER IN SIZE." THIS INCREASE IN PRONG DIAMETER CAUSED OCCLUSION OF THE PATIENT'S NARES. THE "DIRECTIONS FOR USE" FOR THIS PARTICULAR CANNULA RECOMMEND ONLY A 60-80% OCCLUSIONS OF THE NARES. THE STAFF REMOVED THE CANNULA AND REPLACED IT WITH A NEW ONE. PER THE STAFF AS OF (B)(6) 2014, THE PATIENT WAS "STABLE" AND NO LONGER USING A CANNULA. THE EVENT WAS NOT FORMALLY DOCUMENTED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170851 NEOTECH RAM CANNULA NASAL OXYGEN CANNULA CAT NEOTECH PRODUCTS, INC. N4904

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Required Intervention