Field Safety Notices about Infusion sets Comfort, Comfort Short

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Unomedical a/s.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
  • Event Country
  • Event Source
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Extra notes in the data
  • Reason
    As part of unomedical a/s product quality monitoring process, we identified an increase in reports of the tubing becoming detached at the connect/disconnect location on the infusion sets comfort, comfort short and contact detach (please see images below). while the number of these reports remains low, we are notifying you of this potential issue because your safety and experience with our products is our top priority. if tubing detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify you. the interruption of insulin delivery can cause hyperglycemia, which if left untreated, can result in diabetic ketoacidosis (dka). dka is a serious condition that can cause a severe impact to health, including death. symptoms of dka may include nausea, vomiting, shortness of breath and excess thirst/urination. seek medical attention immediately if you are experiencing any of these symptoms. .