Additional information was added to h3, h4 and h6.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation. visual inspection was performed to the photograph using the naked eye which revealed a kinked tube which did not allow the medication to flow.The reported condition was verified.The cause of the condition was due to a manufacturing issue; an excess of solvent applied during assembly.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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