Additional information: d4: expiration date, d9, h3, h4, h6 and h11.H4: the lot was manufactured between august 1 and august 3, 2023.H11: the actual device was received for evaluation.A visual inspection was performed, and fluid was observed inside a bag that contained the unit.When the unit was removed from the bag, the cause of the leak inside the bag was found to be an untightened 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 winged luer cap.The winged luer cap was securely connected to the device and a functional leak test was performed, and no signs of leak were observed (see attached photos).Based on the sample analysis finding, the device was determined to be conforming product because no evidence of leak was observed during the functional leak test.The product label (ifu, instructions for use) indicates, ¿ensure that the winged luer cap is securely connected after filling and priming.¿ the reported condition was verified during visual inspection; however, not verified during functional testing.The cause of the condition could not be determined; however, a probable cause may be due to a use error by not securely tightening the blue winged cap.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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