Investigation summary: bd received samples and photos from the customer facility for investigation.The samples and photos were evaluated and tested, 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 issue relating to foreign matter was not observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.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, a root cause could not be determined.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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