A further clinical review was performed and identified this event to be mdr reportable pursuant to 21 cfr part 803.A lot history review could not be performed as the lot number is unk.The investigation is inconclusive as the sample was not returned.The definitive root cause could not be determined based upon the available info.It is unk if patient and/or procedural issues contributed to the reported event.The info provided by bard represents all of the known info at this time.Despite good faith efforts to obtain additional info, the complaint/ reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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