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), used evacuator.Visual inspection of the sample noted create negative pressure with (in-house) evacuator tubing attached to port a of the evacuator and placed in a reservoir of methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and the evacuator bulb was fully inflated with no crack or damages noted.No root cause could be found because the reported event was unconfirmed.The device history record review could not be performed without a lot number.As the reported event is unconfirmed a labeling review is not required.H11: section a through f - 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.H3 other text: the actual/suspected device was inspected.
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