Correction made to d4: lot #: 22n018 (previously submitted as asku).Correction made to d4: unique identifier (udi) #: (b)(4) (previously submitted as ni).H4: the lot was manufactured from december 07, 2022 - december 08, 2022.H10: the device was received for evaluation.The device contained no fluid in the bladder because the luer was not closed and the fluid had emptied inside a bag.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional flow rate test was performed and the flow rate was found to be within the product specification range.During the flow test, evidence of continuous flow of fluid was observed coming out at the distal luer.The reported condition was not verified.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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