Events

Alerta De Seguridad para Central Venous Catheter Double Lumen, 4Fx13cm, Model CS-14402, Registration No. 10216830011, lot: RF1069600.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Gabmed Produtos Específicos Ltda..

¿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
  • ID del evento
    1220
  • Fecha
    2013-01-09
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    According to the manifestation of the company, the use of the product with deviation of the quality can cause in the stay of part of the guidewire within the vein of the patient. The company requests to observe the batch number of the products in stock and, if the lot involved in the collection, please contact the distributor. Email to contact: calidad@gabmed.com.br####ERROR: 02/20/2013 - The company forwards documentation of the destruction of the collected products, thus finalizing this field action. ####
  • Causa
    The company holding the registry has identified recurrence in reports describing that the catheter guidewire has ruptured.
  • Acción
    The company that owns the registration in Brazil is collecting the product. The collected parts will be segregated until the manufacturer's report (International Arrow, located in the United States) is delivered and the company can decide on the final destination of the products collected.

Device

Central Venous Catheter Double Lumen, 4Fx13cm, Model CS-14402, Registration No. 10216830011, lot:...

Manufacturer

Gabmed Produtos Específicos Ltda.