(b)(4).The device was received and evaluated for the reported event.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Underwater leak testing was performed with flow obstruction observed in the assembly between the injection site and the tube.Therefore, the reported condition was verified.The cause was determined to be excess solvent during the assembly process.A capa has been opened to address this 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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