Additional infoirmation added to d9, h3, h6 and h10.H10: the device was received for evaluation.The visual inspection by naked eye of the product showed the product dry.On one side of the housing, two brownish dried drops at the outside of the housing was visible.The 'particulate matter inside fluid path' could not be confirmed.The failure 'particulate matter outside fluid path' could be confirmed.The dried drops could be scratched off.The reported condition was not verified.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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