Additional information added to d10, h3, h6 and h10.H10/h11: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was received for evaluation.The visual inspection of the provide pictures showed the product was dry.A black particulate matter at the header of the product was visible.It was not visible if the particle was inside or outside of the product.The visual inspection by naked eye of the actual product showed the product was dry.A particulate matter on the outer side of the product between the header cap and the housing was visible.The reported condition was verified.The material analysis showed that the particulate matter was made of rubber and was identical to the material of the closing caps of the saline solution.Therefore the particulate matter is not product related.Should additional relevant information become available, a supplemental report will be submitted.
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