Additional information was added to d9, h3, h6, and h10.H10: the device was returned for evaluation.Visual inspection was performed and the white twist clamp will not fully engage into the locking position.Leak, clear passage, and clamp function testing were performed, and no leaks were observed through the closed clamp; however, the blue notch will not align with the detent on the white clamp.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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