Additional information was added to d9, h3, h4, and h6.H4: the lot was manufactured from february 25, 2020 - february 26, 2020.H10: the device was received for evaluation.The top left corner was cut where the customer likely drained the contents.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.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 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.
|