The reported event is inconclusive due to poor sample condition.Visual evaluation of the sample noted one sealed non-bard urinalysis cup filled with clear fluid and a with a dark clump inside without the bulb syringe mentioned in the complaint.The current condition of the irrigation bulb syringe remains unknown.A potential root cause for this reported failure could be defective / contaminated components from supplier.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 use of an ifu does not apply to the reported event.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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