The sample was not returned and the lot number of the affected product was not provided; therefore, a complete investigation could not be performed and a root cause could not be determined.This event may be associated with a voluntary safety alert submitted by terumo on december 8, 2015.The safety alert number is 1124841-12/08/2015-004-c.(b)(4).Method: no testing methods performed.Results: no results available since no evaluation performed.Conclusions: unable to confirm complaint; device not returned.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.
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