H.6.Investigation summary: bd had not received samples, but a video was provided for investigation.The video was evaluated and shows the hemogard closure assembly being put on and taken off the tube; however, the video does not show the customer's failure mode.There is no specimen in the tube.Additionally, one hundred (100) retention samples from bd inventory were visually inspected with the hemogard closure assembly correctly assembled and placed on the tubes.There were no cocked stoppers identified that would cause the hemogard closure assembly to not be applied correctly.10 retention samples were draw tested with all weights being within specification limits.No issues with the hemogard closure assembly being loose or separating during or after the draw testing was completed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
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