Investigation summary: no product or photos of the reported defect were returned for investigation.The customer complaint of a chemo leak incident with one of the secondary lines could not be verified due to the product not being returned for failure investigation.A device history record review for model 10014881 lot number 21069687 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 16jun2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
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