Events

Safety Alert Or Field Safety Notices for Steel cannula infusion sets

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 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
    Safety alert / Field Safety Notice
  • Event Number
    MDA/2015/027
  • Date
    2015-07-23
  • Event Date Posted
    2015-07-23
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/steel-cannula-infusion-sets-risk-of-needle-breaking-in-use
  • 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
    Unomedical a/s issued an FSN in May 2015 to distributors but does not know where all the sets were sent.
  • Reason
    (unomedical a/s) may cause leakage of medication and require surgical intervention to remove the needle (mda/2015/027).
  • Action
    Ensure all users are aware of the potential for the set’s needle to break (see field safety notice (FSN) for details of affected sets). Ensure procedures are in place for all users, including patients, to: check the infusion sets prior to use and do not use sets with bent or damaged needles remove sets carefully and check that they are intact after use receive and understand the instructions for use contact a health care provider for clinical assessment if a needle has broken

Device

Steel cannula infusion sets
  • Model / Serial
  • Product Description
    The following steel cannula infusion sets are affected:SURE-T SURE-T Paradigm contact detach contact Sub Q neria neria detach neria multi thalasetFurther device details including lot numbers and item numbers are in the manufacturer’s FSN.
  • Manufacturer
    Unomedical a/s

Manufacturer

Unomedical a/s
  • Manufacturer Address
    Cindie Vandfeldt Telephone: +45 4642 7880Email: FSCA-ID@convatec.com
  • Manufacturer Parent Company (2017)
    Triona Holding Sa
  • Source
    MHRA