A manufacturing review was conducted.Lot met all release criteria.The complaint investigation is inconclusive as the sample was not returned for evaluation.Based on the available information, the definitive root cause is unknown.Section a through d: the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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