The reported issue was confirmed.The root cause of the reported issue was a failed mixing pump.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The complaint or reported issue was confirmed through other elements of the investigation to not be labeling related.Hence, labeling review was not required.Correction: f, g, h.H11: section a through f - 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.H3 other text : the device was not returned.
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