Events

Alerta De Seguridad para BD CATETER INTRAVENOUS CENTRAL HYDROCATH AND ACCESSORIES - Record: 10033430196 - Lots: 111121/111405/201348

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Becton Dickinson Indústrias Cirúrgicas 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
    806
  • Fecha
    2005-05-13
  • 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
    Due to market decisions, the product BD Catheter Central Intravenous HydrocathTM and Accessories was discontinued in the year 2000. Due to this, the registration was not revalidated with ANVISA, and its expiration in March 2004.
  • Causa
    Bd singapore (manufacturer) received 4 entries that the sealing of the primary packaging (tray versus cap) was incomplete, which could compromise the sterility of the product. it has been reported that bd singapore has not received any reports of increased infection rate related to the use of these products during the last 5 years. however, the evaluation of the manufacturing process identified a failure during packaging and, as a precautionary measure, the manufacturer is collecting all kits that were marketed after 1999, the date the current sealing process was implemented.
  • Acción
    No action involving the aforementioned product, since, due to market decisions, the product BD Catheter Central Intravenous HydrocathTM and Accessories had its commercialization interrupted in the year 2000. Due to this the registration was not revalidated with ANVISA, with its maturity in March of 2004. (Registration holder information)

Device

BD CATETER INTRAVENOUS CENTRAL HYDROCATH AND ACCESSORIES - Record: 10033430196 - Lots: 111121/111...

Manufacturer

Becton Dickinson Indústrias Cirúrgicas Ltda
  • Source
    ANVSANVISA