Events

Safety Alert for Beacon Tip Catheters

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

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
    2016-04-27
  • Event Date Posted
    2016-04-27
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160427.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: cook medical beacon tip catheters the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning beacon tip catheters [multiple products affected and multiple catalogue numbers affected], manufactured by cook medical. the manufacturer has identified an increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. the preliminary investigation has identified that environmental conditions, such as storage temperature, humidity, and the use of vaporized hydrogen peroxide (vhp) for whole-room decontamination within healthcare facilities, may be contributing to the occurrence. it is recognised that there may be other undetermined contributors to this issue and continue to investigate. potential adverse events that may occur as a result of catheter polymer degradation include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs. the manufacturer is advising users to quarantine and return any unused product. according to the local supplier, the affected products are distributed in hong kong. for details, please refer to the tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2016-rn-00483-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 27 april 2016.

Device

Beacon Tip Catheters
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Cook Medical Beacon Tip Catheters
  • Manufacturer
    Cook Medical

Manufacturer

Cook Medical