Date of birth: only the patient's age was provided, therefore a default date of birth has been listed.Fda notified: the initial reporter also notified the fda via medwatch # (b)(4).Investigation summary: a complaint of a white substance being found in the male luer, making it difficult to connect to another set was received from the customer.A sample was returned for investigation.Through visual inspection the customer complaint was confirmed.There was a white piece of matter stuck in the male luer.An ftir analysis was performed on the sample.The foreign matter is most likely dihydrocarvone, an additive commonly used in the food and flavor industry.A secondary set was attached to the set easily, but was very difficult to disconnect.A device history record review for model 2426-0007 lot number 21045794 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 13apr2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the foreign matter was an error in the manufacturing process.The foreign matter is the cause for the connection issues.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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