The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "incorrect operation".It was unknown whether the device had met relevant specifications.The product was not used on the patient.It was unknown whether the product had caused the reported failure.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.A labeling review was not performed because labeling could not have prevented the reported failure.H11: section a through f - the information provided by bd represents all 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.H3 other text: the device was not returned.
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