Events

Alerta De Seguridad para CERTOFIX DUO V 720 JUG 7F and CERTOFIX DUO V 730 SUB 7F Technical name: FAMILY OF CENTRAL VENOUS CATHETERS ANVISA Registration Number: 80136990671 Hazard Class: IV Affected Model: 4161211 and 4161319 Serial Numbers Affected: 16M15A8551 and 16M21A8551

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
    2212
  • Fecha
    2017-03-03
  • 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
    Interruption of the use of said lot numbers, segregation thereof and information to Laboratorios B. Braun SA, for collection.
  • Causa
    We have communicated that the possibility of disconnection between the female luer connector and the certofix catheter extension line has been identified. such deviation was identified by the manufacturer during the production process because the female luer connector was not fully inserted in the extension line.
  • Acción
    Field Action Code AC / 01/2017 triggered under the responsibility of the company Laboratorios B. Braun SA Company will make payment.

Device

CERTOFIX DUO V 720 JUG 7F and CERTOFIX DUO V 730 SUB 7F Technical name: FAMILY OF CENTRAL VENOUS ...

Manufacturer

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