Other text: additional information in h3, h6 and h10.This mdr was generated under protocol (b)(4)as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.Leak test inspection was performed on the returned device and it did not present leakage.Based on the leak test results, the reported nonconformance is not confirmed.Root cause cannot be determined since the failure mode reported is not confirmed.No corrective actions were taken since the investigation did not reveal the failure reported.No problems or issues were identified during this device history record review.
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