The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "machine speed out of parameters.".It was unknown whether the device had met relevant specifications.The device history record review could not be performed without a lot number.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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