No lot number was provided.A review of the device history report (dhr) was unable to be performed.However, all dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.No product/sample was provided for evaluation.No additional information, pictures or videos were received.Therefore, a comprehensive investigation was unable to be conducted.Manufacturing performs 100% leak testing for this product.Therefore, a leakage would have been detected during these processes.The reported customer complaint could not be confirmed.A root cause could not be determined.No corrective or preventive action is deemed necessary at this time.This complaint will be utilized for tracking and trending purposes.
|