The device was received for evaluation containing approximately 120 ml of drug fluid in the bladder.During visual inspection, the fillport¿s lip was observed ¿chipped off on one side¿.The reported condition was verified; however, the cause of the condition could not be determined.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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