Additional information was added to h3, h6, and h10.H10: the device was returned for evaluation.Visual inspection was performed, and it was noted that the white twist clamp will not fully align with the notch of the main body.Leak and clear passage testing were performed and no issues were observed.Clamp function testing was performed and the twist clamp closed not allowing flow through the set; however, the clamp will not fully lock in position.The reported condition was verified.The cause of the condition was determined to be a manufacturing related issue which occurred during the milling process.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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