Additional information: h3, h6 and h10.H10: the actual device was not available for evaluation, however, pictures were provided.The visual inspection of the five provided photos showed the product after use.Photo one showed the product barcode, photo two and three are showed the header area and photo four and five are showed the product label.Since the product is not in use anymore and the leak is not clearly shown, the reported condition could neither be confirmed nor excluded.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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