Events

Alerta De Seguridad para Spinocath - Spinal Anesthesia Kit Technical Name: Anesthesia Kit ANVISA Registration Number: 10008530204 Hazard Class: II Affected Model: 4517725 Serial numbers Affected: lot: 2I20018501

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Laboratórios B. Braun S.A.; B. Braun Melsungen 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
    2119
  • Fecha
    2016-09-20
  • 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
    Interruption of the use of said lot, segregation thereof, information to B. Braun SA Laboratories of the quantities of existing units of this batch number for collection.
  • Causa
    It was identified the possibility of holes in the pvc film, responsible for performing a sterile barrier to the product spinocath g22. this type of orifice was verified in pvc film with thermoforming measuring 25mm. it is important to note that laboratorios b. braun sa canceled the registration of the item in question in 2014. however, it was identified the sale of 40 units of lot 2i20018501, (manufactured on 09/20/2012 and dated maturity for 09/2017) to a single customer, who had, in the year 2012, a relationship as distributor of products of b. braun sa.
  • Acción
    Field Action Code AC / 02/2016 triggered under the responsibility of the company Laboratorios B. Braun SA Company will collect for further destruction.

Device

Spinocath - Spinal Anesthesia Kit Technical Name: Anesthesia Kit ANVISA Registration Number: 1000...

Manufacturer

Laboratórios B. Braun S.A.; B. Braun Melsungen AG