Events

Safety Alert Or Field Safety Notices for Nasogastric feeding tubes – Ryles tubes (weighted tip)

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 Ltd.

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/2013/009
  • Event Number
    CON239462
  • Date
    2013-02-26
  • Event Date Posted
    2013-02-26
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON239462?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 incorrect placement of the feeding tube due to incorrectly applied depth markings. despite issuing two field safety notices in january 2013, vygon ltd has not received sufficient confirmation from users that they have received and acted on this information.
  • Action
    Identify and quarantine any affected devices. Ensure all users are aware of the manufacturer’s Field Safety Notices (dated 3 January 2013 and 21 January 2013). Return the confirmation requests in the FSNs to the manufacturer. If patients have affected tubes in situ, confirm correct placement before further use, following local protocols.

Device

Nasogastric feeding tubes – Ryles tubes (weighted tip)
  • Model / Serial
  • Product Description
    Nasogastric feeding tubes – Ryles tubes (weighted tip). Size 12FG 125cm, product code: 392.12, lot number: 160412FG. Size 14FG 125cm, product code: 392.14, lot number: 100512FF. The affected product codes on the manufacturer’s website and device labels are specified as ‘392.12’ and ‘392.14‘.  The same products are referred to as ‘0392.12’ and ‘0392.14’ respectively in the manufacturer’s Field Safety Notices.
  • Manufacturer
    Vygon Ltd

Manufacturer

Vygon Ltd