Investigation summary bd received samples and photos from the customer facility for investigation.The samples and photos were evaluated and the customer's indicated failure mode for foreign matter with the incident lot was observed.Additionally, retention samples were selected from bd inventory for evaluation and upon completion, the customer's indicated failure mode for foreign matter was not observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Investigation conclusion: based on evaluation of the customer photos, the customer¿s indicated failure mode for foreign matter with the incident lot was observed.Evaluation of the customer samples was conducted and foreign matter was observed.Additionally, evaluation of the retain samples was conducted and foreign matter was not observed.Root cause description: based on the investigation, the most likely root cause was determined to be related to manufacturing process where tube is in between additive filling and evacuation.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.
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