The actual device was not available; however, a photos of the sample were provided for evaluation.The visual inspection of the provided photos showed the product unpacked and dry.Photo one showed the product with the product label.Photo two showed a brownish particle on the header cap in the top area of the blood port.The reported condition was verified.The cause is manufacturing related.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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