Events

Safety Alert Or Field Safety Notices for Reinforced endotracheal (ET) tubes – Murphy; Magill; Murphy with stylet; Magill with stylet

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 ConvaTec company).

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/2013/029
  • Event Number
    CON272226
  • Event Date Posted
    2013-05-08
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON272226?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
    Potential for inadequate patient ventilation. the affected tubes may delaminate, which can lead to constriction of the lumen, resulting in a reduction of airflow to the patient. the manufacturer issued a field safety notice, dated 13 march 2013, to withdraw the affected devices but has not had confirmation from a significant number of users that they have received and acted upon this information. this alert has been issued in support of the manufacturer’s actions. delamination is the detachment of the plastic inner layers of the endotracheal tube from one another because of poor adhesion. the problem has now been rectified.
  • Action
    Identify, quarantine and do not use affected devices. Seek alternative devices immediately. Return affected devices and the recall questionnaire to the manufacturer.

Device

Reinforced endotracheal (ET) tubes – Murphy; Magill; Murphy with stylet; Magill with stylet
  • Model / Serial
  • Product Description
    Reinforced endotracheal (ET) tubes – Murphy; Magill; Murphy with stylet; Magill with stylet. Available under three brand names: Unomedical UnoFlex TM EuromedicalTM TrachealFlex TM PharmaPlast Specific sizes and lots are affected. Reinforced endotracheal tubes are single-use medical devices comprised of an armoured, hollow cylinder inserted orally or nasally into the trachea. Pages four to six of the Field Safety Notice (FSN) provide guidance on how to identify the devices. The reference numbers and lot numbers of all the affected devices are listed on pages 10 to 38 of the FSN.
  • Manufacturer
    Unomedical (a ConvaTec company)

Manufacturer

Unomedical (a ConvaTec company)