BEUDAMED
    FDA Adverse Event Summary report: N

    RAPICIDE OPA 28

    MDR report key: 3812340 · Received May 15, 2014

    Report

    Report Number
    2150060-2014-00016
    Date Received
    May 15, 2014
    Date of Event
    April 17, 2014
    Report Date
    May 9, 2014
    Manufacturer
    MEDIVATORS
    Product Code
    MED
    PMA / PMN Number
    K120306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CASE STATES THAT THIS FACILITY WERE COLD SOAKING NASAL CANNULA'S USED FOR NITROUS OXIDE DELIVERY USING RAPICIDE OPA 28 HIGH LEVEL DISINFECTANT. AFTER MEDIVATORS INVESTIGATION INTO THIS COMPLAINT, IT WAS DISCOVERED THAT NONE OF THE NASAL CANNULAS WERE BEING RINSED AT ALL. IT WAS REPORTED THERE WERE TWO DEFINITE AND ONE MAY BE PATIENTS AFFECTED BY THE CHEMICAL EXPOSURE AND HAD A REACTION ON THEIR NOSE AND CHEEKS. MEDIVATORS PRINCIPAL TECHNICAL SPECIALIST CONTACTED THIS FACILITY AND DISCOVERED THE FACILITY'S PROCEDURE WAS INCORRECT. THEY ARE NOW AWARE OF THE IMPORTANCE OF RINSING THE CHEMISTRY OFF THE NASAL CANNULAS PRIOR TO USE ON PATIENTS. THERE IS LIMITED INFORMATION REGARDING THE PATIENTS AFFECTED. TO DATE, THERE ARE NO REPORTS OF PROLONGED INJURY OR ILLNESS OR ADDITIONAL MEDICAL ATTENTION BEING SOUGHT KNOWN BY THE MANUFACTURER, MEDIVATORS. MEDIVATORS WILL CONTINUE TO MONITOR THIS COMPLAINT.

    Description of Event or Problem · 1

    FACILITY NOT RINSING NASAL CANNULAS USED ON PATIENTS ON NITROUS. PATIENT CHEMICAL REACTION REPORTED. 3 PATIENTS COMPLAINED OF BROWN SPOTS AND BUMPS ON THEIR NOSE AND/OR CHEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291951 RAPICIDE OPA 28 HIGH LEVEL DISINFECTANT MED MEDIVATORS ML02-0127

    Patients

    Seq Age Sex Outcome Treatment
    1