H10: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing was performed.Visual inspection detected that inflation line was not fully adhered to the tube surface, however marks of solvent can be appreciated.Functional testing found the cuff was unable stay completely inflated leak was detected in join between tube and inflation line; thus, failure mode is confirmed.The root cause of the reported issue was found to be manufacturing procedure not followed.An awareness complaint notification to the production personnel was conducted by quality engineer on 05-jan-2023 for the defect reported by the customer.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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