The incident sample has been requested but to date has not been received for evaluation. if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
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A review of the device history record (dhr) was completed and there were no nonconforming events documented.All dhr¿s are reviewed for accuracy prior to product release.No samples were submitted with the complaint however, 7 photographs were provided and reviewed which show what appears to be a stack of containers with breakage in the corner rim of the top 3 containers and what appears to be 1 lid cracked in the lid assembly.The potential root cause for the reported issue is that the containers and/or lids cracked during shipping and handling due to external stress/forces after manufacture.Based on the existing controls, and the complaint history review, additional correction or containment activities are not warranted at this time.Product is routinely examined to ensure it meets all acceptance quality limits.All lots are statistically sampled and inspected for deficiencies prior to release.A lot cannot be released unless it meets all acceptance requirements.This will be used for tracking and trending purposes.
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