The reported event is unconfirmed as the problem could not be reproduced.Visual evaluation of the returned sample noted one opened (no original packaging), unused silicone foley.Visual inspection of the sample noted no bubbles.A potential root cause could not be found since the reported event was unconfirmed.A labeling review was not performed because labelling could not have prevented the reported failure.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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