The information provided by bard 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 bard.The device has not been returned to the manufacturer, at this time, for evaluation.A history review of serial number (b)(4) found a similar complaint reported on record number (b)(4).The root cause was unconfirmed as the reported issue of poor image quality was unconfirmed during evaluation.The device has not been returned to the manufacturer, at this time, for evaluation.
|