Investigation summary: no product or photo was returned by the customer.The customer complaint of leaking between tubing and filter, as well as the filter crack, could not be verified due to the product not being returned for failure investigation.Device history record review for model 10011865 lot number 22049156 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 21apr2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of this failure could not be identified without a failure investigation.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
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