Events

Alerta De Seguridad para Disposable Needles: INSUPEN- Sensitive - 4/6/12 mm x 0.23 mm (32 G); Original - 12mm x 0.33mm (29G), Registration No. 80134900006, lots: 1001202752; 1001206754; 1001207760; 1031203752; 1041203752; 1051203752; 1051206751; 1021206720; 1031203751; 1031206720; 1031207751; 1041204751; 1001202755; 1001204751; 1001207736; 1011201752; 1011207736; 1021206736; 1031206736; 1051202752; 1051203752; 1011205752; 1021202752; 1041205753; 1041207751; 1051205753; 1206720; 1210751; 1210752

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Sanofi-Aventis Farmacêutica 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
    1332
  • Fecha
    2013-12-02
  • 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 concluded that the deviation of the quality specification found implies a low risk to the patients' health.////////// UPDATE - 05/28/2014 - The company finalized the field action and the units collected were for destruction.
  • Causa
    The company detected quality deviations, according to reports made to technovigilance, on insupen needles, manufactured in italy by the company artsana. such a deviation can cause a disconnection between the plastic and metallic components of the needle, probably caused by transport under adverse conditions.
  • Acción
    The company that owns the registration in Brazil is collecting the product.

Device

Disposable Needles: INSUPEN- Sensitive - 4/6/12 mm x 0.23 mm (32 G); Original - 12mm x 0.33mm (29...

Manufacturer

Sanofi-Aventis Farmacêutica Ltda.
  • Empresa matriz del fabricante (2017)
    Sanofi
  • Source
    ANVSANVISA