The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because the user could not have caused the reported issue so labeling does not apply.A potential failure mode could be ¿component damaged or defective¿ with a potential root cause of ¿defective or damaged material received from supplier¿.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.H3 other text : the device was not returned.
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