Events

Safety Alert Or Field Safety Notices for Neonatal endotracheal tube SCP 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 Capatex 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/2012/029
  • Event Number
    CON152757
  • Date
    2012-05-24
  • Event Date Posted
    2012-05-24
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON152757?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 or airway obstruction, as a result of over-tightening of the clamp/holder. capatex is recalling affected products and has advised users of the issue in field safety notices (see appendix). this medical device alert is being issued to reinforce the manufacturer’s actions. a change was made to the composition of the plastic material used, to make the clamps/holder dehp-free. this affected the physical properties of the clamps, resulting in an increased risk of slippage. to counteract this, capatex added an extra notch on the clamp. however, this introduced the possibility of over-tightening and occlusion of the internal diameter of the endotracheal tube. all clamps from lot number 1002854 onwards have been manufactured using a new material.
  • Action
    Identify affected devices and quarantine them. Contact Capatex to arrange for devices to be exchanged or to confirm that you have none in stock. Follow the advice in the FSN dated February 2012 (see appendix). In particular, follow advice on Capatex clamp/holder size and corresponding size of endotracheal tube to be used.

Device

Neonatal endotracheal tube SCP clamp/holder
  • Model / Serial
  • Product Description
    Neonatal endotracheal tube SCP clamp/holder. Product codes: CM – SCP020 – ENDO CM – SCP025 – ENDO CM – SCP030 – ENDO CM – SCP035 – ENDO CM – SCP040 – ENDO Lot numbers up to and including 1002853
  • Manufacturer
    Capatex Medical

Manufacturer

Capatex Medical