The customer's address is unknown.(b)(6) has been used as a default.(b)(4).Investigation summary: a device history record review was completed for provided material number 306413 and lot number 022362n.The review did not reveal any detected quality issues during the production process that could have contributed to this reported defect.To aid in the investigation, thirteen samples were received in their sealed packaging flow wrap for evaluation by our quality team.A visual inspection was performed with no damage or other imperfections observed and the barcode was verified with the scanner.Investigation conclusion: complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Root cause description: based on the investigation results, the samples received did not show the symptom reported by the customer and an exact cause for this incident could not be identified.Rationale: there are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.
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