The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.The product was used for treatment.The product had not caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used reliavac evacuator with tubing and drain.Visual inspection of the sample noted no obvious visible defects.The drain was placed in a reservoir of methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water).Evacuator balloon was inflated by engaging the bulb at the top of the device.Balloon was fully inflated with no difficulty and port b was closed off to create negative pressure.Balloon began to deflate and suction water.The device suctioned 400cc of water as intended so air leaks do not seem to have occurred.This does meets the acceptance criteria outlined, no root cause could be found because the reported event was unconfirmed.The device was returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.As the reported event is unconfirmed a labeling review is not required.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 actual/suspected device was inspected.
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