Additional information was added to d10, h3, h4 and h6.H4: the lot was manufactured from january 28, 2020 - january 29, 2020.H10: three (3) actual samples were received for evaluation.Unaided visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed which revealed a leak between the spike port cap tube and the spike port bind area in all samples.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 applied to the spike port cap tube when it was inserted to the spike port causing an incorrect bonding 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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