Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), specifications, trends, quality control, and review of photos was conducted during the investigation.The complaint device was not returned; therefore, no physical examination could be performed.A document-based investigation was performed.Review of the device history record of the finished product shows no nonconforming events that are related to the reported failure.There were no other reported complaints for this lot number.Photos were obtained and reviewed.The photos show what appears to be a circular shape puncture that is less than 1 cm in diameter in the clear packaging.Based on the information provided, no product returned, and the results of our investigation; the root cause has been determined to be related to shipping and handling.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.
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