The reason for this complaint was reported as mislabeling of an item.The healthcare professional indicated that the event occurred during surgery, near the patient.There was no risk or adverse event reported by the surgeon.There was a five (5) minute delay in surgery but the surgery was completed as intended.The agent was present when the event occurred and was able to provide another suitable device.A review of the device history records (dhr) wo# (b)(4) and wo# (b)(4) indicates that both lots were for 17 pieces.Both work orders were processed by the same operator through flow bench verification and tray kit assembly and were processed by the same operator through seal - tray assembly.The labels on the bottom of the tray, petg, and outer packaging all match.There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event.A review of the complaint databased identified for the same lots and for the same alleged issue.The root cause of this complaint is likely due to the parts were swapped between the part verification/tray kitting and the tray seal operation.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
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