Investigation summary: one photo of primary set, model 2426-0007, was received by the customer for investigation.Upon visual inspection, it could be observed that the base of the 2nd smartsite needleless connector had disconnected from the tubing.No other defects were observed.The customer's complaint that the iv tubing separated at the y site was verified.A device history record review for model 2426-0007 lot number 21079235 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 02jul2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Since no physical sample received, an investigation could not be performed and a root cause could not be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: since no physical sample received, an investigation could not be performed and a root cause could not be determined.
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