A review of the device history record could not be conducted as the lot number was reported as unknown.A photograph was submitted for evaluation; a leak is observed; the reported condition is confirmed.Disassembly and leakage were confirmed through the photo sample.During the investigation, a review of the manufacturing process was conducted.In general, all process and controls were found properly followed, including sub-assemblies, finished product assembly and packaging.There were no abnormal conditions found that could trigger the reported condition.The root cause for the reported condition could not be determined without a physical sample to evaluate.The manufacturing site will continue to monitor customer complaints and feedback notifications for adverse trends that require immediate attention.An awareness notification was issued to production personnel to heighten awareness of the condition reported through a quality alert.
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