The reported event was inconclusive.No sample was returned for evaluation.The potential root cause for this failure mode could be user related (example: salt accumulation)/ block drainage lumen/ no or undersize drainage eye.The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labeling review due to unknown product code.Although the product family was unknown, the foley catheter product ifus were found to be adequate based on past reviews.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.
|