The actual date of event is unknown.Device evaluated by bd service and not returned to manufacturing facility for evaluation.A review of the device history record showed the device had a manufacture date of 29apr2016 the review was performed from the date of manufacture to the present date 19apr2021.A review of the device history record for sn (b)(4) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.A review of the complaint history record in was performed for the sn (b)(4) which did not confirm similar complaints with the same or related failure mode.A review of the service history record for sn (b)(4) was performed which confirmed that this device was not involved in a service failure which correlates to the customer reported issue.
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