Events

Alerta De Seguridad para Trade Name: Closed System Urine Collection Fellowships Technical Name: Collectors ANVISA Registration Number: 80136990508 Hazard Class: I Model Affected: UREOFIX 500 CLASSIC, EB. 2.0L, TUBE 120CM (4417930) Serial numbers affected: Item 4417930 / lot: 16F01E8SUA.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Laboratórios B. Braun S.A.; B. Braun Melsungen AG.

¿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
    2118
  • Fecha
    2016-11-04
  • 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
    Take measures to ensure that the use of the product units belonging to the abovementioned lot is interrupted and segregate the remaining units so that they can be collected by Laboratorios B. Braun SA
  • Causa
    A change in performance of the ureofix 500 classic hourly diurese manifold has been identified. this is due to the possibility of the first compartment of the product emptying its contents before it is completely filled, migrating the urine into the second compartment of this collector. emptying the first compartment makes it difficult to read the patient's diuresis.
  • Acción
    Field Action Code AC / 04/2016 triggered under the responsibility of the company Laboratorios B. Braun SA Company will collect for further destruction.

Device

Trade Name: Closed System Urine Collection Fellowships Technical Name: Collectors ANVISA Registra...

Manufacturer

Laboratórios B. Braun S.A.; B. Braun Melsungen AG