Additional information was added to d10, h3, h4 and h6.H4: the potential lot number 802869 manufactured date is august 21, 2019.H4: the potential lot number 802858 manufactured date is july 15, 2019.H10: the actual sample was received for evaluation.Unaided visual inspection was performed which observed that the spike was detached from the tubing.Due to the nature of the returned sample, no additional testing could be performed.The reported condition was verified.The cause of the condition was not determined; however, the most likely cause was due to inadequate or lack of cyclohexanone being applied to the spike or tubing in 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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