BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNO OPTI-MIST + NEB 210CM (10/50) INT

    MDR report key: 4905057 · Received July 8, 2015

    Report

    Report Number
    9680866-2015-00044
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Report Date
    June 17, 2015
    Manufacturer
    UNOMEDICAL S.A. DE C.V.
    Product Code
    CAF
    PMA / PMN Number
    K791536
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PREVIOUS INVESTIGATION HAS BEEN CLOSED. TWO ROOT CAUSES WERE IDENTIFIED. THE JET WAS BEING PRODUCED IN AN OLD INJECTION MOLDING MACHINE THAT WAS NOT CONDITIONED WITH AN ALARM TO DETECT AND PREVENT THE VARIATION (DOUBLE CYCLE) IN THE PROCESS. THIS MACHINE HAS BEEN DISCONTINUED. INADEQUATE INSPECTION PROCESS FOR NEBULIZERS. CORRECTIVE ACTION HAS BEEN IMPLEMENTED TO INCLUDE: VERIFYING ALL ACTIVE MOLDING MACHINES TO CONFIRM ALL HAVE INTEGRATED THE REQUIRED ALARMS. CREATE A TEMPORARY QUALITY ALERT TO INSPECT NEBULIZER COMPONENTS EVERY 2 HOURS AS OUR INSPECTION PROCESS IS UPDATED. CREATION OF A TEST METHOD FOR INSPECTION OF MOLDED COMPONENTS (NEBULIZER SET AND JET). CREATE A TEST METHOD FOR INSPECTION OF MOLDED COMPONENTS, CLARIFY ALL DETAILS OF PROCESS TO DO THE MIXING AND ADD A FORM TO RECORD THE AMOUNT OF RESIN AND MATERIAL USED IN EACH MIXING, DETERMINE WATER FLOW RATES, WATER TEMPERATURE AND PRESSURE, AND INCLUDE PROCESS PARAMETERS TO BE MONITORED. DETERMINED THE EXPECTED SHELF LIFE OF PINS FOR THE ORIFICE OF CUP AND JET, AND ESTABLISH ITS REPLACEMENT IN THE ADEQUATE PERIOD OF TIME. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON DECEMBER 29, 2015.

    Additional Manufacturer Narrative · 1

    CORRECTION HAS BEEN MADE TO SECTION E.1 (INITIAL REPORTER PHONE #) AS THIS WAS SUBMITTED ON THE INITIAL MDR INCORRECTLY (B)(6), 2015. THIS INFORMATION WAS DISCOVERED (B)(6) 2015. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON JULY 28, 2015 REGARDING THE ACTUAL PRODUCT REPORTED: INITIALLY THE PRODUCT REPORTED WAS THE ICC CODE 3772MM ADULT AND THIS WAS CONFIRMED; HOWEVER, RETURNED SAMPLE WAS LABELED WITH ICC CODE 3773MM, LOT # 105415. A QUALITY COMPLAINT INVESTIGATION WAS PERFORMED ON THE SAMPLE RECEIVED INDICATING ICC CODE 3773MM, LOT # 105415. ONE USED SAMPLE WAS RECEIVED ON JULY 16, 2015. DIMENSIONAL INSPECTION - INTERNAL DIAMETERS OF ORIFICES WERE FOUND WITHIN SPECIFICATION. FUNCTIONAL TEST (NEBULIZATION): MINIMUM AEROSOL OUTPUT DOES NOT MEET 1.5ML REQUIREMENT AT THE LOWER FLOW RATE (6 1/MM). INVESTIGATION PERFORMED BY QUALITY DEPARTMENT OF THE MANUFACTURING SITE INDICATED THAT PRODUCT FAILED TO MEET THE MINIMUM AEROSOL OUT PUT (1.5 ML) REQUIREMENT SPECIFIED IN CONVATEC TEST PROCEDURE. A PREVIOUS INVESTIGATION IS APPLICABLE TO THIS COMPLAINT INVESTIGATION AND WILL BE LEVERAGED. THIS PREVIOUS INVESTIGATION IS OPEN. THEREFORE, THIS COMPLAINT WILL REMAIN OPEN UNTIL COMPLETION OF THE PREVIOUS INVESTIGATION. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON AUGUST 04, 2015.

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN REQUESTED. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE COMPLAINT INVOLVES (B)(4) DEVICES THEREFORE A SEPARATE FDA 3500A WILL BE SUBMITTED FOR EACH COMPLAINT.

    Description of Event or Problem · 1

    THE NURSE REPORTS THE UNO OPTI-MIST + NEB FAILED TO NEBULIZE MEDICATION. SHE NOTED THE "FLUID IN THE NEBULIZER IS JUST SPARKLING/BUBBLING; THERE WASN'T ANY DUST COMING OUT". SHE FURTHER REPORTED THERE WERE NO KINKS IN THE OXYGEN LINE; AIR/OXYGEN COULD BE DETECTED COMING THROUGH THE MASK AND THERE WERE NO CONNECTION OR DIFFICULTIES WITH THE CONNECTIONS. SHE REPORTS THE DEVICE WAS REPLACED FOUR TIMES WITH NEW UNO OPTI-MIST + NEBULIZERS AND ALL DEVICES FAILED TO NEBULIZE MEDICATION. THE NURSE FURTHER REPORTS A FIFTH UNO OPTI-MIST + NEB WAS USED WHICH OPERATED APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443229 UNO OPTI-MIST + NEB 210CM (10/50) INT NEBULIZER (DIRECT PATIENT INTERFACE) CAF UNOMEDICAL S.A. DE C.V. 3772MM

    Patients

    Seq Age Sex Outcome Treatment
    1