The reported event was inconclusive because no sample was returned.It was unknown whether the device had met relevant specifications.Based on patient code 2645 the product was not used on the patient.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be ¿incorrect operation ¿.The lot number was unknown; therefore, the device history record could not be reviewed.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 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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