Additional information was added to d4 (lot#), (expiration date), (udi#), d9, h3, h4, and h6.D4: lot #: the lot # is ¿60210023¿, previously submitted as ¿asku¿.D4: expiration date: the expiration date is ¿09/30/2022¿, previously submitted as ¿ni¿.D4: udi #: (b)(4), previously submitted as ¿ni¿.H4: the lot was manufactured from october 11, 2019 ¿ october 15, 2019.H10: the device was received for evaluation.Unaided visual inspection was performed did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed which revealed a leak only on the left side, approximately at the 400 ml area in back of the bag.Additional magnified inspection was performed which verified a tear/hole where the leak occurred.The reported condition was verified.The cause of the condition 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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