Initial reporter address: (b)(6).The actual device was not available; however, three photographs of the sample were provided for evaluation.Visual inspection of the provided picture shows in photograph number one the product out of the packaging with part of label.The second photograph shows the barcode is visible and the product is wet.Photograph three shows the product from a further distance with part of the product label.The reported condition was verified.The most likely cause of the condition is due to a crack in the housing nearby the welding zone.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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