Events

Alerta De Seguridad O Notificaciones De Seguridad para Reinforced endotracheal (ET) tubes – Murphy; Magill; Murphy with stylet; Magill with stylet

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Unomedical (a ConvaTec company).

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2013/029
  • Número del evento
    CON272226
  • Fecha de publicación del evento
    2013-05-08
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON272226?tabName=allTabs
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
  • Descripción del producto
    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)