Events

Alerta De Seguridad para Protect-A-Line IV extension set

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

¿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
    2013-08-20
  • Fecha de publicación del evento
    2013-08-20
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130820a.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: vygon protect-a-line iv extension set the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) issued a medical device alert concerning protect-a-line iv extension set (supplied with vented caps) manufactured by vygon. the affected product code is 0832.04 and all batch numbers ending in the letters ba are affected. according to the mhra, there is a risk of air embolus because the affected devices have been supplied with vented caps on the female port (y-site) instead of non-vented caps. identify affected devices. prior to use, remove vented caps from the female port (y-site) of affected devices and replace them with non-vented caps (or a needle free connector) if this port is to remain unused when the set is connected to a patient. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/publications/safetywarnings/medicaldevicealerts/con306143 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 august 2013.

Device

Protect-A-Line IV extension set
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Vygon Protect-A-Line IV extension set
  • Manufacturer
    Vygon

Manufacturer

Vygon