The reported event was inconclusive because no sample was returned for evaluation.A potential root cause for this failure could be "inspection results (measurement, testing data) not verified by iqa assignee error of inspector".The lot number was unknown; therefore, the device history record could not be reviewed.A labeling review is not required because labeling could not have prevented the reported issue.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.
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