Events

Alerta De Seguridad para Trade name: Intego CSS (SAS). ANVISA registration number: 80384380024. Risk class: II. Affected template: INT CSS. No. of lots: 50515057, 50812469, 50827615, 50837233, 50881512, 60001558, 60001864, 60003127, 60003368, 60004159, 60004454, 60005487, 60006545, 60008270, 60008271.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Bayer SA; Bayer Medical Care Inc..

¿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
    2051
  • Fecha
    2016-11-18
  • 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
    Bayer makes the following recommendations: Discontinue use of its Intego System and determine an alternative method for radiopharmaceutical delivery, such as manual injections, if possible; Bayer points out that there is no record of the occurrence of the possible problems mentioned above in any patient, as a consequence of this fact. In addition, Bayer is in the process of analyzing the possibility of solving the problem by qualifying an in-line filter that is compatible with Intego CSS (SAS).
  • Causa
    Bayer has identified that all current intego css extenders (sas) used with the integra medrad® pet infusion system can receive particles from the radiopharmaceutical (rp) bottle when the needle is inserted. the particles may be generated when the needle tip applies force through the rubberized bottle cap. we clarify that there is no record of occurrence of the possible consequences mentioned below in any patient, as a result of this fact, so that it is a preventive action.
  • Acción
    Field Action Code AS-16-RAD-09 triggered under the responsibility of Bayer SA a) Classification of risk: Class II. b) Classification of the field action: It is an action of field of recollection, whose destination of the products collected is the destruction. c) Field action code: SA-16-RAD-09.

Device

Trade name: Intego CSS (SAS). ANVISA registration number: 80384380024. Risk class: II. Affected t...

Manufacturer

Bayer SA; Bayer Medical Care Inc.
  • Empresa matriz del fabricante (2017)
    Bayer AG
  • Source
    ANVSANVISA