H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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.
|
It was reported that approximately two months post a dialysis catheter placement, the catheter allegedly had to be removed as a semi-emergency measure due to a leak.It was further reported that when water was injected through the branches of the removed catheter, a drop of water allegedly appeared at the point on the root of the red branch where the branches bifurcate.Furthermore, air bubbles were allegedly noted.Reportedly, the catheter was replaced.There was no reported patient injury.
|