Events

Safety Alert for Arterial Venous Fistula (AVF) sets for Haemodialysis - Safety AVF Needle fixed wing

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Kawasumi Laboratories Inc.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-11-26
  • Event Date Posted
    2015-11-26
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151126b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: kawasumi laboratories inc. arterial venous fistula (avf) sets for haemodialysis - safety avf needle fixed wing 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.

Device

Arterial Venous Fistula (AVF) sets for Haemodialysis - Safety AVF Needle fixed wing
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Kawasumi Laboratories Inc. Arterial Venous Fistula (AVF) sets for Haemodialysis - Safety AVF Needle fixed wing
  • Manufacturer
    Kawasumi Laboratories Inc

Manufacturer

Kawasumi Laboratories Inc