Investigation summary: one unused primary set, model 2426-0500, was received by the customer for investigation.Upon visual inspection, it could be observed that the set's middle smartsite needleless connector was disconnected from the tubing.No other defects were observed.The customer's complaint that when tubing was removed from packaging, the item was disconnected at a y site was verified.A device history record review for model 2426-0500 lot number 19125907 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 08mar2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Visual inspection under magnification was performed on both the internal and external tubing engagement components.Investigation conclusion: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: it could be identified that the solvent had not been properly applied to the tubing during the assembly process.
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