The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 18-apr-2022.H6: investigation summary: one sample was provided to our quality team for investigation.Through visual inspection, no damage or defects were observed that could have contributed to the reported incident.Functional testing was performed, attempting to pass liquid through the fluid channel and it was found the channel was blocked.After clearing the channel, a flow test was performed and liquid was able to successfully move through the device without issue.Characterization testing was performed on the substance found to be blocking the channel and identified it was calcified drug that was used with the device.Product undergoes a series of inspections throughout the manufacturing process to ensure the quality and functionality of the device, including flow rate verification.As the lot involved in this incident is unknown, a device history review could not be performed.Based on the sample evaluation, the root cause of this incident is related to calcification of the drug, blocking proper flow of fluid.
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