H4: the lot was manufactured from may 12, 2020 ¿ may 14, 2020.H10: two (2) actual samples were received for evaluation.Unaided visual inspection did not identify any abnormalities that could have contributed to the reported condition.The clamps were functionally tested which observed that both samples required excessive pressure to close the clamps.Additionally, damage was observed after closing the clamp of one (1) sample.The reported condition was verified.The cause of the condition is manufacturing related.This issue is being further investigated.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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