BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON RCI

    MDR report key: 852073 · Received May 17, 2007

    Report

    Report Number
    9680866-2007-00002
    Event Type
    Malfunction
    Date Received
    May 17, 2007
    Date of Event
    May 2, 2007
    Report Date
    May 16, 2007
    Manufacturer
    UNOMEDICAL INC.
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIRTEEN (13) UNOPENED SAMPLES FROM THE SAME LOTS WERE REC'D DIRECTLY FROM MAIN DISTRIBUTOR. PRODUCT WAS MFR BY UNOMEDICAL INC. SAMPLES WERE EVALUATED BY UNOMEDICAL FOLLOWING THE MFG TEST PROCEDURE. VISUAL EXAMINATION OF RETURNED SAMPLES DEMONSTRATED NO VISUAL DEFECTS INCLUDING KINKED TUBES OR NASAL PRONGS. IN ADDITION SAMPLES WERE TESTED UNDER SIMULATING USE CONDITIONS BY PLACING THE DEVICE OVER THE FACE OF A MANNEQUIN. NASAL KINKING PROBLEM COULD NOT BE REPRODUCED. EXAMINATION OF BATCH RECORDS OF LOT REPORTED (06-21) DID NOT INDICATE ANY NONCONFORMITY PRODUCT DURING IN-PROCESS AND FINAL INSPECTION. COMPLAINT FILE FOR THE LAST THREE YEARS WAS REVIEWED AND NO SIMILAR COMPLAINT OF THIS NATURE WAS FOUND. ONLY FIVE COMPLAINTS HAVE BEEN REPORTED DURING THE SAME PERIOD OF TIME. NONE OF THE COMPLAINTS REPORTED HAVE BEEN ATTRIBUTED TO KINKING PROBLEM. UNOMEDICAL HAS CONCLUDED THAT SAMPLES RETURNED MEET THE SPECIFICATION REQUIREMENTS. WE ARE CONSIDERING THIS REPORT AS AN ISOLATED MAL FUNCTION PROBLEM. NO FURTHER ACTIONS WILL BE TAKING AT THIS POINT UNLESS MORE COMPLAINT OF THE SAME NATURE IS REC'D.

    Description of Event or Problem · 1

    THE CANNULA IS EXTREMELY SOFT AND FLEXIBLE AND HAS RESULTED IN TWO REPORTED INCIDENTS OF THE NASAL CANNULA KINKING, CAUSING THE BABY TO DESATURATE (BLUE) AND BECOME BRADYCARDIC (HEART RATE DROPS). MALFUNCTION OCCURRED IN ANOTHER COUNTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON RCI SOFTECH NASAL CANNULA CAT UNOMEDICAL INC. 1828 06-21

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization