H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported leak.Functional testing with tap water was performed, and a leak was identified from the spike port bonding area.The reported condition was verified.The cause of the condition could not be determined; however, the most probable cause was due to inadequate or lack of cyclohexanone applied to the spike port cap tube when it was inserted into 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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