The reported event was inconclusive, as no sample returned for evaluation.A potential root cause for this failure mode could be due to ¿material incompatibility¿.It was unknown whether the device had met specifications.The product used for treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labelling review was not performed due to the labelling could not prevent the reported failure.H11:section a through f - the information provided by bd 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 bd.
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