H4: the lot was manufactured between october 28, 2022 and october 29, 2022.H10: the device was received for evaluation.An unaided visual inspection was performed which observed a leak at the administration port bonding area.The bag was cleaned, and with the approximately 300ml of the filled solution in the returned product, a leakage from the administration port bonding area was observed.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 cap tube when it was inserted into the spike port during the manufacturing process.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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