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.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
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A device history record could not be reviewed because a lot number could not be provided by the customer.A product analysis was unable to be completed as to date no samples or pictures have been provided.Precluding any further information or evidence there is not enough information at this time to determine with any confidence what likely caused the reported issue.Potential root causes for the issue are: mold damage, misaligned threading or issues with the port on the braun #490402 ext.Set.If additional information or evidence becomes available, the complaint will be reopened and the root cause reassessed.This issue has been determined to be an isolated event.The product should be inspected prior to use for any damage.Based on existing controls, and the complaint history, neither corrective nor preventive actions are warranted at this time.
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