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
    2050
  • Fecha
    2016-10-31
  • 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
    User and patient recommendations: Users are encouraged to review their current INT CSS (SAS) inventories, identify products with more than one year of manufacture, discontinue use by quarantining them immediately, and contact the Bayer Customer Service Department, to return the product to Bayer properly.
  • Causa
    According to the company, it has been identified that intego css (sas) used with intego pet medrad®, with a validity of 3 years, can present failures in situations of occlusion, when it is more than 1 year, from the time of manufacture. therefore, there may be a leakage of both saline and radiopharmaceutical into the ionization chamber, resulting in the application of an incomplete dose, which may require repetition of the examination and may also cause possible radiation exposure to the operator if the camera is open. it has been discovered that the cause is the insufficient or uneven application of adhesive during manufacture, resulting in a possible failure of the pvc pipe connection. internal tests showed that the failure occurred in products with use in a period of more than 1 year, causing obstruction of the css extender (sas) during injection. the most common causes of occlusion are a stopcock valve in incorrect position or closures that have not been removed from the tubes.
  • Acción
    Classification of risk: Class III. Field action classification: Collection of products, which will be destined for destruction. Field Action Code: AS-16-RAD-06. User and patient recommendations: Users are encouraged to review their current INT CSS (SAS) inventories, identify products with more than one year of manufacture, discontinue use by quarantining them immediately, and contact the Bayer Customer Service Department, to return the product to Bayer properly.

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