Based on the available information, this event is deemed 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.This complaint involves at east 50 devices but, the exact quantity is unknown and could not be confirmed by the complainant.
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Additional information: an investigation was performed on one used returned sample and no discrepancies were noted.Sample was tested to verify the minimum aerosol output at the lower flow rate.Sample met 1.5 ml minimum aerosol output requirement, it delivered 1.66 ml.There is not enough information to conclude the product did not meet specification and perform as intended.Product monitoring reviews will monitor for product trends if this issue were to reoccur.Although the sample did meet specifications, a related capa/event was leveraged to investigate nebulizer issues (poor or no mist).This complaint will remain open pending the conclusion of the investigation.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).
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Previous investigation leveraged for this complain and the investigation is completed.Two root causes were identified.1.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.2.Inadequate inspection process for nebulizers.Corrective action has been implemented to include: 1)verifying all active molding machines to confirm all have integrated the required alarms.2)create a temporary quality alert to inspect nebulizer components every 2 hours as our inspection process is updated.3)creation of a test method for inspection of molded components (nebulizer set and jet).4)create a test method for inspection of molded components, 5)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, 6)determine water flow rates, water temperature and pressure, and include process parameters to be monitored.7)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, (b)(4).
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