The device and photographs of the sample were received for evaluation.The visual inspection of the provided pictures shows the product out of the original packaging and a pur (polyurethan) residual inside the dialysate port (blue arrow).The visual inspection by naked eyes of the product shows the product dry and without protection caps.The dialysate port is marked with a blue arrow.At this marking, as in the picture, a pur residue (film) can be seen in the dialysate port.No damage was found on the dialysate port.A pur-film can occur in the dialysate port (hansen connector) due to the potting process; however, this is not a product failure.The reported condition could not be verified.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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