H4: the device was manufactured from july 15, 2022 to july 16, 2022.H10: the actual devices were not available; however, twelve (12) companion samples were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing observed leakage at the spike port bonding area and the spike port tube of one (1) randomly selected companion sample.The cause was not determined; however, the potential cause was due to inadequate or lack of cyclohexanone being applied to the cap tubing when it was inserted to the spike port causing an incorrect bonding 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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