The following fields were updated due to additional information: d.9.Device available for eval?: yes, d.9.Returned to manufacturer on: 10-apr-2022.H.6.Investigation: infusion bag and c180j connector were received for investigation.Upon visual inspection, no defect was found in the membrane, nor in the spike needle of the connector.Foreign matter particles were observed inside the infusion bag.Fourier transform infrared spectroscopy was performed to identify the foreign matter.The foreign substance was composed of butyl rubber and silicic acid compounds, usually coming from the rubber stopper of the syringe and also from the phaseal membrane (talcum powder).A device history review was performed for reported lot 2104204 , 2105004 2104110 , no deviations or non-conformances were identified during the manufacturing process that could have contributed to this reported issue.Fragmentation testing is performed according to procedure, to evaluate any particulates generated by the injector when mated to other components after ten activations.While phaseal needles are designed to reduce coring, there are several factors that may impact coring tendency.Coring from the membrane may occur due to fragmentation caused by multiple injections or excessive welding of the membrane.Coring of the rubber stopper may result depending on the stopper quality, the design and dimensions of the needles used, or if a poor connection of the protector occurs, or if an incorrect stopper is used as in this case.The product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification that all critical dimensions are within specification and that there is no damage to the product.Based on the quality team's investigation, a root cause related to our manufacturing process cannot be identified at this time.This foreign matter could be determined by the type of quality of this stopper, quality of the cannulas or incorrect use.It is important to ensure that the vial is not expired, as this may affect the quality of the rubber stopper.
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