H.6.Investigation summary: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for lot 1905109, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Three retained samples of the same lot were used for additional evaluation.The product was visually inspected and no defects were identified.Functional testing was performed, connecting the injector to a sample syringe, protector and vial according to the instructions for use.Liquid was withdrawn from the vial and the injector was then connected to a connector and disconnected, repeating this process three times.In all cases the product functioned properly, and no issues were observed.It is important to hold onto the white components of the injector when engaging/disengaging; and not grip the blue safety sleeve.If not done properly, the safety sleeve may become disengaged which can result in the needle becoming exposed.To avoid damage to the safety sleeve grips, it cannot be forcefully engaged.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.Complaints received for this defect and device will continue to be monitored by our quality team for signs of emerging trends.H3 other text : see section h.10.
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