Investigation summary: bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for poor gel barrier separation with the incident lot was observed.Additionally, retention samples were selected from bd inventory for evaluation & testing and upon completion, all samples separated as expected with complete impervious gel barriers.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 poor gel barrier separation with the incident lot was observed.Additionally, evaluation/testing of the retain samples was conducted and no issues were observed relating to the quality and performance of the gel barrier.Root cause description: based on the investigation, a root cause could not be determined.
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