H4: the lot was manufactured between august 12, 2022 to august 13, 2022.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 a leak was observed at the spike port bonding area only.The reported condition was verified.The cause of the condition could not be determined but most likely 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.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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