Root cause: a sample picture of the defective product was provided and confirmed that the incorrect gauze was in the convenience kit.The true root cause was identified as a pulling and assembly error.Corrective action: the puller and assembler responsible for this error were retrained on the internal work order processing procedure (acd.Qlp.034) with specific focus on the section regarding tray assembly descriptions and verifying component numbers by catalog numbers.Investigation summary: an internal complaint (call 48004) was received indicating that an ent nasal tray (finished good 89-9341, lot 49821627) contained non x-ray detectable gauze when it should have contained x-ray detectable gauze.A sample was not available for return.However, a picture of the defective sample was provided and confirmed the reported incident.The work order was reviewed for discrepancies that may have contributed to the reported event.No discrepancies were found.No shortages or defects were noted on this work order.The affected raw material was identified as component 5-20327, a 4 x 4 x-ray detectable gauze.The inventory was checked and found to be correct.No gauze was mixed on the shelf and no returns were found for the reported tray lot.The investigation is complete at this time.If new and critical information is received, this report will be updated.
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