The Therapeutic Goods Administration (TGA) of Australia has posted a medical device safety alert concerning the Arterial Venous Fistula (AVF) sets for Haemodialysis - Safety AVF Needle fixed wing manufactured by Kawasumi Laboratories Inc.
The affected catalogue numbers are AVFE1525CLFG and AVFE1525CPLFG and the affected lot numbers include 140714I8, 141014I5, 141110I1, 150128I7, 150511I1, 140912I6, 141110I2.
The manufacturer has received four reports worldwide where the needle cannula of the Arterial Venous Fistula set for Haemodialysis had separated from the needle hub and remained in the patient's vein when attempting to remove the needle following the completion of the dialysis treatment. Although the possibility of occurrence for such an event is extremely low, there is potential that blood leakage could occur should the needle cannula separate from the hub and remain in the patient's vein.
There have been no reports of patient injury as a result of this issue.
The manufacturer advises users to stop using the affected products from the affected population. Customers are advised to quarantine and destroy all affected products in the affected population.
For details, please refer to the TGA website:
http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2015-RN-01147-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 26 November 2015