Investigation summary: bd received samples from the customer facility for investigation.The samples were draw tested with bd vacutainer tubes and following filling of the tubes, the safety push button was activated.All samples activated correctly with the iv needle retracting completely while remaining safely locked within the needle housing.Therefore, the product met all required 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 samples, the customer¿s indicated failure mode for a non-retracted iv needle during activation of the safety push button 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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