Events

Alerta De Seguridad para Trade name: BLOOD COLLECTION PACKAGING CPDA-1 Technical name: BLOOD COLLECTION PACKAGE ANVISA registration number: 10154450076 Hazard class: III Model affected: COMPOFLEX 1F CPDA-1 Serial numbers affected: 71IM03AC00; 71IM04AB00; 71KH16AD00

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por FRESENIUS HEMOCARE BRASIL LTDA; FRESENIUS HEMOCARE BRASIL 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
    2253
  • Fecha
    2017-03-29
  • 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
    If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Causa
    The company received a report from a distributor, where it was informed about the occurrence of molded packaging labels of the product compoflex 1f cpda-1, lots: 71kh16ad00, 71kl19aa00 and 71kh17ac00. the company identified fungal growth on the label on the primary packaging of the product. after internal investigations, it was possible to conclude that the residual steam from the sterilization process combined with the paper label of this package was the cause of such a deviation. it was also verified that the sterility of the bags was not compromised and that it is only a damage on the label itself, and can be framed as a cosmetic deviation. although there is absolutely no indication that the sterility of the bags is compromised, fresenius hemocare has decided, as a precautionary measure, to collect these batches of the product.
  • Acción
    Field Action Code 01-2017 triggered under the responsibility of the company FRESENIUS HEMOCARE BRASIL LTDA. Company will collect.

Device

Trade name: BLOOD COLLECTION PACKAGING CPDA-1 Technical name: BLOOD COLLECTION PACKAGE ANVISA reg...

Manufacturer

FRESENIUS HEMOCARE BRASIL LTDA; FRESENIUS HEMOCARE BRASIL LTDA