H10: the actual device and five pictures were received for evaluation.The visual inspection of the provided pictures showed the product wet and a black hair like particulate matter was observed in or on the header cap.The visual inspection by naked eyes of the actual sample showed the product wet.A black particulate matter was observed in the header cap.The reported condition was verified.The cause was production process related.After removing the header cap, a scratch on the inner surface of the cap was also observed.This was a black discoloration that could be removed.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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