Events

Safety Alert Or Field Safety Notices for Neonatal and paediatric endotracheal tube clamp/holder

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 EMS Medical.

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/2012/049
  • Event Number
    CON174833
  • Date
    2012-07-23
  • Event Date Posted
    2012-07-23
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON174833?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 airway loss due to slippage of the clamp/holder or airway obstruction as a result of over-tightening of the clamp/holder. ems medical has gone into administration and therefore cannot be contacted.   the mhra has issued this medical device alert to ensure that all users are aware of this issue. the composition of the plastic used to make the clamp/holder was changed to a dehp-free material. this affected the physical properties of these components, resulting in an increased risk of slippage or tube obstruction. ems medical went into administration before this issue was identified and it is not known how many affected devices have been supplied.
  • Action
    Identify, do not use and dispose of affected devices.

Device

Neonatal and paediatric endotracheal tube clamp/holder
  • Model / Serial
  • Product Description
    Neonatal and paediatric endotracheal tube clamp/holder. All product codes. All lot numbers. This device assists in securing an endotracheal tube (ETT) in position for neonatal and paediatric patients.
  • Manufacturer
    EMS Medical

Manufacturer

EMS Medical
  • Source
    MHRA