The device history record was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the defect described by the customer.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The component was manufactured on 03/28/2020.The actual device or images were not submitted for evaluation.Since the actual device was not received for evaluation, the condition reported could not be confirmed.A gemba walk was performed in the manufacturing area with the multifunctional team (quality, manufacturing, engineering) and determined that this defect could not occur at the manufacturing floor or during the packaging and shipping step.It is important to note that this component is sold as a raw material, and it¿s packaged as bulk; the component is subjected to a subsequent process, therefore it is not possible to determine the exact root cause of the issue.The current molding process conditions were reviewed, and it was confirmed that all manufacturing procedures are being followed properly, no condition was found that may contribute directly to the reported condition.The failure mode reported by the customer was not confirmed, no action plan is deemed required.The current process is running according to product specifications meeting quality acceptance criteria.We will continue to monitor trends and utilize the information as part of continuous improvement.
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