(b)(4).A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.The sample was not returned for evaluation.Since the actual sample was not returned, ten pieces of the same catalog number were taken from current production at the manufacturing facility to test the reported defect.The samples were all visually inspected and no issues were observed.In addition, leak testing was also performed on all ten samples, and no leaks were detected.Because no sample was returned, the complaint could not be confirmed.In the current manufacturing procedure, 100% leak testing is conducted at the assembly area; therefore, any defects would be detected prior to release.
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