The following fields have been updated with additional information: d9: device available for evaluation: yes.D9: returned to manufacturer on: 2022-11-28.H.6.Investigation summary: "bd received 40 samples from the customer in support of this complaint.10 samples, along with 10 retention samples from the bd inventory, were functionally tested and the issue of overfill was not observed as all tubes were within specification limits.Bd was unable to confirm and duplicate the customer¿s indicated failure mode because the defect was not observed in the sample and retention testing.Bd was unable to determine a root cause for the reported issue.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.Sufficient volume is achieved when the blood draw falls above the minimum fill indicator and below the bottom of the shield.The quantity of blood drawn into evaluated tubes varies with altitude, ambient temperature, barometric pressure, tube age, venous pressure, and filling technique." h3 other text : see h.10.
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