It was reported that after indwelling the temperature sensing foley catheter, there was no outflow of urine, so it was discontinued and removed.Also, it was confirmed from the funnel side that there was no outflow and a possibility of blockage.
|
The reported event was confirmed as manufacturing related.1 sample was confirmed to exhibit the reported failure.The device has not met specifications.The product was used for treatment.The product had caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used temperature sensing silicone foley catheter.Visual inspection of the sample noted no obvious visible observations.Attempted to flush the catheter, and solution did not advance through the funnel.Upon further inspection, there appeared to be excess material in the funnel.This is out of specification per inspection procedure ip7601841, revision 11, which states, "check for defects: excessive material (over fill), bubbles/voids, splits and/or blemishes".A potential root cause for this failure could be incorrect setup.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labeling could not have prevented the reported failure.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.
|