The system was used for treatment.A batch record review of kit lot e336 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot e336 for the reported complaint issue shows no trends.Trends were reviewed for complaint category, pressure dome membrane leak.No trends were detected for this complaint category.The assessment is based on information available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.(b)(4).Device not returned to manufacturer.
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