Additional information was added to d10, h3, h4 and h6.H4: the lot was manufactured from august 12, 2020 ¿ august 13, 2020.H10: two (2) actual samples were received for evaluation.Unaided visual inspection was performed which observed that the tube set tubing with detached spike found loose in the primary packaging in both samples.Additional magnified inspection was performed which revealed a lack of adhesive.The reported condition was verified.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 at the spike connection to the tubing.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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