H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection was performed on the photograph using the naked eye and a damaged/separated port was identified.The reported condition was verified.The cause of the condition could not be determined; however, a probable cause could be related to the environmental conditions where the product is stored and constantly exposed to light.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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