Events

Alerta De Seguridad para Neonatal Endotracheal Tube SCP Clamp/Holders

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Capatex Medical.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2012-05-25
  • Fecha de publicación del evento
    2012-05-25
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120525.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: capatex neonatal endotracheal tube scp clamp/holders the medicines and healthcare products regulatory agency (mhra), united kingdom issued a medical device alert concerning neonatal endotracheal tube scp clamp/holder manufactured by capatex medical. the manufacturer is recalling the products prior to batch 1002854. according to the mhra, 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. as a result, there is a risk of airway loss due to slippage or airway obstruction. the manufacturer recommended that checks must be made to ensure the endotracheal tube is not slipping or being compressed. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/medicaldevicealerts/ index.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted 25 may 2012.

Device

Neonatal Endotracheal Tube SCP Clamp/Holders
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Capatex Neonatal Endotracheal Tube SCP Clamp/Holders
  • Manufacturer
    Capatex Medical

Manufacturer

Capatex Medical