Alerta De Seguridad para ELS SYRINGE FOR ANGIOGRAPHY GUERBET - Model: 00 000 000 3160 25, Registro ANVISA: 10061400027

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MEDTRON 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
    1354
  • Fecha
    2014-02-06
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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
    Blue particles from the protective caps of the syringes may eventually come loose into the syringes. This occurs due to friction in the material when the protective cap is threaded during the syringe manufacturing process. The friction can cause wear and consequently, the particle generated in this friction can fall into the syringe. The cause identified for this quality deviation was a tool modification by the manufacturer of the product. The consequences may range from local redness to involvement of the microcirculation with blood vessel obstruction and phlebitis, as well as possible damage to organs such as the lungs, liver, kidneys and spleen due to the formation of granulomas. According to the registry holder in Brazil, no incident notification has been received so far. The actions have already been taken by the manufacturer and the problem has been eliminated in production. In order to avoid any risk to patients, the involved lots will be collected and destroyed.
  • Causa
    It has been shown that blue particles from the protective caps of the syringes may eventually fall into the syringes.
  • Acción
    Gathering and destruction

Manufacturer