Additional information was added to d9, h3, h4, h6 and h10.Correction to d4 lot# and udi#.D4: the correct lot# is 60220328, previously submitted as asku.D4: the correct udi# is (b)(4), previously submitted as ni.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed and observed an immediate leak at the spike port bonding area.The reported condition was verified.The cause of the condition could not be determined; however, the probable cause of the leak was due to inadequate or lack of cyclohexanone applied to the spike port cap 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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