The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
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A review of the device history record showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.There were no deviations or nonconformances initiated with this lot code.A sample was not received with this complaint therefore, it is not possible to confirm the reported condition.From a root cause analysis perspective, gel delamination could occur if the silver printed carbon substrate does not bond with the gel, or liner.The results of the manufacturing facility investigation were unable to confirm an exact root cause associated with the manufacture of product the root cause and action plan will be documented through a formal corrective/preventative action (capa) which has been initiated to address the reported condition to mitigate any further occurrences.This action is currently ongoing.This complaint will be closed with no further action and will be used for tracking and trending purposes.This complaint will be recorded for tracking and trending purposes.
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