Additional information : one actual sample was received for evaluation.A visual inspection with naked eye noted a hole in the rf seal of the bag.Functional testing, including leak testing, clear passage testing and clamp function testing was performed; leak testing failed due to a leak through the hole at rf seal.The reported condition was verified.The direct cause of the event was determined to be manufacturing related.A nonconformance has been opened to address this issue.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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