H4: the lot was manufactured from may 15, 2020 - may 19, 2020.H10: the actual device was received for evaluation.Unaided visual inspection was performed which observed that the finger grip connector was detached from the tubing.Further testing was performed and no leak or spike detachment was observed.The reported condition of spike that was separated from the tubing was not verified.The cause of the detached grip connector could not be determined.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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