H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The actual sample and pictures were provided for investigation.The visual inspection of the eight provided photos showed the unpacked product.The photos showed the product (header area) with a broken dialysate port.The last two photos also show the part of the broken dialysate port.The visual inspection by naked eye of the actual product showed two products dry and one product wet.On all three products, the dialysate port was observed to have broken off.The reported condition was verified.For the two dry products the residual part of the dialysate port was not available.On the wet product, the broken dialysate port had a heavy damage at the opening of the dialysate port.The cause could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
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