Qn#(b)(4).A device history record (dhr) review could not be performed as the lot number was unknown.The actual sample was not returned for evaluation; therefore, the complaint could not be confirmed.In the current manufacturing procedure, 100% leak testing is conducted at the assembly area; therefore, a defect of this type would be detected prior to release.Ten samples were selected from current production at the manufacturing facility and inspected.No defects were found on the samples.They all passed a visual exam and leak testing.If the sample is returned, a follow-up report will be submitted with investigation results.
|