Additional information was added to d9, h3, h4 and h6.H4: device manufacture date: april 28, 2020 - april 29, 2020.H10: four (4) devices were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed, which revealed a leak at the spike port bonding area in all samples.The cause of the condition could not be determined.However, the most likely cause was, due to inadequate or lack of cyclohexanone applied to the spike port tube when it was inserted to the spike port, during the manufacturing process causing an incorrect bonding.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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