Investigation summary: bd received samples and photos from the customer facility for investigation.The photos were evaluated and the customer¿s indicated failure mode for coring with the incident lot was not observed.Additionally, evaluation/testing of the customer samples was performed and coring 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 samples, the customer¿s indicated failure mode for coring with the incident lot was not observed as all samples met the required specifications.Additionally, the photos did not identify a specific product issue.Root cause description: based on the investigation, a root cause could not be determined.The product was found to be in conformance and meet release specifications.
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