Investigation summary: one photo of secondary set, model 10014881, was received by the customer for investigation.Upon visual inspection, it could be observed that the set's drip chamber was disconnected from the tubing.No other defects were observed.The customer's complaint that tubing disconnected from the drip chamber was verified.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.Since no physical sample was 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.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
|