As the lot number for the device was provided, a review of the device history records was 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.(expiry date: 06/2023).
|
It was reported that approximately two months and ten days post dialysis catheter placement procedure, the catheter allegedly was emulsified and became white on the tube closed to the skin.It was further reported that the catheter allegedly bulged.Reportedly, catheter was removed and replaced.There was no reported patient injury.
|