Additional information: d9, h3, h4, h6, h10.H4: the lot was manufactured between january 28, 2023 and january 30, 2023.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional leak test was performed which observed a leak coming out from the administration spike port.The reported condition was verified.The cause of the condition could not be determined; however, is most likely due to inadequate or lack of cyclohexanone being applied to the spike port connector when it was inserted into the spike port tubing during manufacturing.A nonconformance has been opened to address this issue.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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