A batch record review of lot c132 was conducted.There were no nonconformances associated with this lot.The lot met release requirements.Trends were reviewed for complaint category, other adverse event.In this case the other adverse event was numbness and tingling of the lips and mouth.There were no trends detected for this complaint category.No capa was initiated for this complaint category.Based on the medical assessment, the (b)(6) male with chronic gvhd developed numbness and tingling around the lips and mouth during treatment.The patient was administered 8.5% calcium gluconate at 14ml per hour.The patient was stable at the time of the event.This case is serious and related to treatment.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 through the capa/continuous improvement process.(b)(4).
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