Events

Safety Alert Or Field Safety Notices for Protect-A-Line IV extension set (supplied with vented caps)

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Vygon.

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
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2013/067
  • Event Number
    CON306143
  • Date
    2013-08-19
  • Event Date Posted
    2013-08-19
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON306143?tabName=allTabs
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    Risk of air embolus because affected devices have been supplied with vented caps on the female port (y-site) instead of non-vented caps.
  • Action
    Identify affected devices. Prior to use, remove vented caps from the female port (Y-site) of affected devices and replace them with non-vented caps (or a needle free connector) if this port is to remain unused when the set is connected to a patient.

Device

Protect-A-Line IV extension set (supplied with vented caps)
  • Model / Serial
  • Product Description
    Protect-A-Line IV extension set (supplied with vented caps) Product code: 0832.04 All batch numbers ending in the letters BA only.
  • Manufacturer
    Vygon

Manufacturer

Vygon