The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.The product was used for patient treatment.The product had not caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), bulb evacuator with label.Visual inspection of the sample noted connected the (in-house) tubing to the inlet port and the other end of the tubing was placed in a reservoir of methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and the evacuator was flattened to create negative pressure and the solution was able to be suction in the evacuator with no leaks observed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: as the reported event is unconfirmed a labeling review is not required.Correction: d,g,h.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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