The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be ¿tip cover came off during shipping or in processing¿.It is 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.The lot number was unknown; therefore, the device history record could not be reviewed.Labeling review is not required because a review of the label could not have prevented this issue.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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