Additional information was added to d10, h3, h4, and h6.H4 device manufacture date: the device was manufactured from march 03, 2020 to march 04, 2020.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional testing was performed which revealed a leak between the spike port tube and the spike port bonding area.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 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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