Events

Field Safety Notices about Neria Steel Cannula Infusion sets

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland 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
  • Event Number
    SN2012(12)
  • Date
    2012-08-21
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/neria-steel-cannula-infusion-sets-manufactured-by-unomedical&id=0c7ef825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Extra notes in the data
  • Reason
    There is a risk that the needle of the neria steel cannula infusion set may break during use leading to leakage of medication and the potential need for surgical intervention to remove the needle.
  • Action
    1. Ensure that the relevant personnel in your organisation are made aware of this issue.  2. Determine whether you have purchased a device that could be affected by this issue by reviewing the attached FSN.  3. Ensure that all users of these devices are aware of the information supplied by the manufacturer in the attached FSN to ensure safe use of the devices.

Device

Neria Steel Cannula Infusion sets
  • Model / Serial
  • Product Description
    Neria Steel Cannula Infusion sets manufactured by Unomedical
  • Manufacturer
    Unomedical a/s

Manufacturer

Unomedical a/s