A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.One opened but unused introducer needle product was received.Visual and functional testing were performed.Visual inspection found that the introducer needle with the unaided eye, did not reveal any visible defects or anomalies.However, visual inspection (with magnification) showed the inside diameter (id) at the hub of the introducer needle, to be slightly misaligned with the cannula.Functional testing confirmed the complaint.A supplier notification was previously issued to the supplier for the same introducer needle lot number.The finished good from this complaint was manufactured prior to this action.Therefore, this issue has already been addressed through the appropriate channels and no further actions will be taken at this time.Complaint information will continue to be monitored for any new information or adverse trends and further actions will be taken accordingly.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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