Events

Safety Alert Or Field Safety Notices for Nasogastric (NG) feeding tubes

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 Maxter Catheters.

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/2017/035
  • Date
    2017-12-19
  • Event Date Posted
    2017-12-19
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/nasogastric-ng-feeding-tubes-recall-due-to-risk-of-neonatal-or-paediatric-patient-choking-on-enfit-connector-cap
  • 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
    Manufactured by maxter catheters – patients could accidentally pull off the connector cap and choke on it. (mda/2017/035).
  • Action
    Return all unused, affected devices to the manufacturer – product codes of affected stock are listed in the Field Safety Notice (FSN). Ensure relevant healthcare professionals are aware of the FSN. Follow the FSN actions for managing patients with these NG tubes. Fill in the acknowledgement form in Annex 1 of the FSN and return it to the manufacturer.

Device

Nasogastric (NG) feeding tubes

Manufacturer

Maxter Catheters
  • Manufacturer Address
    Maxter Catheters/Halyard Health Tel: +33 491 467 305, +32 2 711 27 19RA.EMEA@hyh.com or
  • Manufacturer Parent Company (2017)
    Halyard Health Inc
  • Source
    MHRA