Additional information was added to d9, h3, h4 and h6.H4: the lot was manufactured from august 12, 2020 - august 13, 2020.H10: two (2) actual devices were received for evaluation.Visual inspection was performed, and the spike was found detached from the tubing of both samples.Functional testing was not performed.However, this detachment would result in a leak.The reported condition was verified for both samples.The cause of the condition could not be determined.However, the most likely cause was, due to inadequate or lack of adhesive being applied, during the manufacturing 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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