The reported event was confirmed as use-related.No sample was returned and unable to determine root cause of reported problem.Based on event description, this was user related issue due to inappropriate foley removal with balloon cuffing.The lot number was unknown; therefore, the device history record could not be reviewed.Labeling review was not performed due to unknown product code.Although the product family was unknown, the foley catheter ifus were found to be adequate based on past reviews.Corrections: d10.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 device was not returned.
|