The device was manufactured from april 10, 2019 - april 11, 2019.The device was received for evaluation.Unaided visual inspection was performed which observed a detached top port tubing from the inside of the bag and protruding outside the back of the bag.Functional testing was performed which revealed the top of the fill port leaking outside the back of the bag when attempting to fill the bag.The reported condition was verified.The cause of the condition was due to a manufacturing related issue.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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