Investigation summary: one photo was provided to our quality team for investigation.Upon visually inspecting the photo, a brown particle was observed between the stopper and plunger.A device history review was performed for the reported lot 2006283, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Manufacturing for this product is performed in a clean room which is kept under a positive pressure to reduce the chance of foreign matter.The assembly machine has a vacuum system to reduce any foreign particles within the syringe.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Without the actual sample to evaluate, we cannot verify the composition or origin of the particle, therefore a definitive root cause cannot be determined at this time.
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