The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction drive tube leak/break.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.A batch record review for kit lot h123 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h123 shows no trends.Trends were reviewed for complaint category, drive tube leak/break.No trends were detected for this complaint category.The assessment is based on the information available at the time of 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.Investigation complete.Mc: (b)(4).S.D.A.(b)(6) 2019.
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