Events

Alerta De Seguridad para DISPOSABLE TECHNICAL NEEDLE FOR ANESTHESIA - Registration: 10033430144, lots: 4222219 and 4217672

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
    809
  • Fecha
    2005-07-27
  • 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
    The company will arrange for the replacement of the units returned by others in accordance with the characteristic standard of the product. If you have any questions or concerns about this information, please contact your local representative or call the Customer Relationship Center at Tel.0800-555456. ANVISA will be accompanying the actions that will be carried out through the company regarding the whole process of collection and replacement of said product.
  • Causa
    Identification of less than normal luer taper.
  • Acción
    Although minor taper does not prevent the use of the product, it should be tightened properly, requiring a 90 ° rotation during the connection between the syringe and the Spinal Needle Cannula. Reviews are being conducted with the mold suppliers to ensure proper preventative maintenance of the molds. Reviews are being conducted with the mold suppliers to ensure the tests performed using the ISO caliber. The areas of Quality Assurance and Projects are developing more sensitive test to detect possible leaks.

Device

DISPOSABLE TECHNICAL NEEDLE FOR ANESTHESIA - Registration: 10033430144, lots: 4222219 and 4217672

Manufacturer

Becton Dickinson Indústrias Cirúrgicas Ltda
  • Source
    ANVSANVISA