A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Because a sample was not returned, we were unable to perform a thorough follow up investigation to include functional and visual evaluations to confirm the reported issue and root cause analysis.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.A potential root cause may be that the product was damaged during shipping and handling due to external stress/forces which may cause the lid to not attach/stay attached.Based on the existing controls, the internal reject and the complaint history review, a formal investigation is not deemed necessary at this time.If additional information is obtained, or the sample is returned, this file will be re-opened for further investigation.This complaint will be used for qa tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.
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