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.The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device was returned to the service facility for evaluation.During evaluation, the reported issue of poor image quality was unconfirmed.Image quality is normal and passed all testing.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.
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