Correction made to d1: brand name: i.V.Administration sets with control-a-flo regulator (previously submitted as.V.Administration sets with control-a-flo regulator) additional information was added to d9, h3, h4, h6 and h10.One (1) actual sample was received for evaluation.A visual inspection was performed and a crack was observed at the female connector.Functional testing was not performed for this complaint.The reported condition was verified.The cause of the condition was due to a manufacturing issue.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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