H4: the lot was manufactured between august 18, 2023 - august 21, 2023.H10: the actual device was received for evaluation.A visual inspection was performed, and it was noted that there was fluid inside the bag that contained the unit.When the unit was removed from the bag, the cause of leak inside the bag was found to be a untightened winged luer cap.No evidence of damage was observed from the unit.Signs of surface roughness were not observed inside the cap when inspected under the microscope.A functional leak test was performed, no signs of leak were observed.Based on the sample analysis finding, the device was determined to be conforming product.A leak was verified from the device.The cause of the leak was use-related due to not securely tightening the blue winged cap.The product label (ifu, instructions for use) indicates, ¿ensure that the winged luer cap is securely connected after filling and priming".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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