(b)(4).The customer did not retain the lot number.The date of manufacture cannot be determined.Medtronic technical support has reviewed the shiley directions for use for ssv and ssvo speaking valve with the reporting physician during a phone discussion.The shiley directions for use for ssv and ssvo speaking valve indicate: on page 2 description: the ssv shiley speaking valve and the ssvo shiley speaking valve with oxygen port are devices with a one-way flutter valve and 15mm femail adapter for use with an appropriately fenestrated or a cuffless tracheostomy tube.On page 3 under warnings: the tracheostomy tube cuff must be completely deflated before placing the shiley speaking valve.Patient will be unable to breathe if cuff is not completely deflated.The event is not device related in that the warnings and ifu were not followed.Patient information (id, age, sex, weight) as well as additional information associated with the complaint have been requested and is either unknown, will not be made available to medtronic, or will be provided and updated in a supplemental report.
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