Investigation summary: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for loose end cap with the incident lot was not observed.Additionally, retention samples were selected from bd inventory for testing and upon completion, the customer's indicated failure mode for loose end cap was not observed as all samples met specifications.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 and retain samples, the customer¿s indicated failure mode for loose end cap with the incident lot was not observed as all samples met the required specifications.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.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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