The device was received for evaluation.Visual inspection with the naked eye found that the product was wet.Two brownish particles were found in the header and luer area of the product.The reported condition was verified.An infrared analysis of the particles was performed.A spectrum could be recorded; however, a suitable comparison spectrum could not be found, therefore a definite statement could not be made about the material.The cause of the condition could not be determined.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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