Additional information: d4, d9, h3, h4, h6, h10.H4: the lot was manufactured between august 3, 2023 - august 4, 2023.H10: the actual device was received for evaluation.A visual inspection was performed, and it was noted that there was a small amount of fluid inside a bag that contained the unit.When the unit was removed from the bag, the cause of the leak was found to be an untightened blue winged luer cap.Signs of surface roughness were not observed inside the cap when inspected under the microscope.Therefore, the cause of leak may be due to a use error by not securely tightening the blue winged luer cap.A functional leak test was performed ensuring the blue winged luer cap is securely connected to the device, and no issues were noted.The device was determined to be a conforming product.The reported condition was verified.The cause of the condition was determined to be user related.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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