Events

Alerta De Seguridad O Notificaciones De Seguridad para Neonatal endotracheal tube SCP clamp/holder

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 Capatex Medical.

¿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/2012/029
  • Número del evento
    CON152757
  • Fecha
    2012-05-24
  • Fecha de publicación del evento
    2012-05-24
  • 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/CON152757?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
    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.
  • Acción
    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
  • Modelo / Serial
  • Descripción del producto
    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