Events

Safety Alert Or Field Safety Notices for unkown device

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 manufacturer #17429.

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/2012/009
  • Event Number
    CON143805
  • Date
    2012-03-01
  • Event Date Posted
    2012-03-01
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON143805?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
    Smiths medical has become aware of an increase in the number of reports of disconnections of the luer lock connector at the patient end of the tubing for these fluid warming sets. this can lead to a risk of fluid/ blood loss or delay in therapy. the mhra cannot be confident that these recalls have been effective and that users have received and acted on the information provided in the manufacturer’s field safety notices (fsns).
  • Action
    Do not use the affected devices. Contact Smiths Medical to arrange the return and replacement of the affected sets as advised in the two Smiths Medical Field Safety Notices (FSNs) issued on 28 November 2011 for: Level 1® Hotline®         The FSNs list the lot numbers of all affected devices. Send the confirmation return form to Smiths Medical. Action by All those involved in the supply and use of these devices.

Device

unkown device

Manufacturer

manufacturer #17429