Events

Alerta De Seguridad para BARD MAGNUM BIOCHEMICAL DISPOSABLE NEEDLE. Anvisa Registration: 10178010157. Product codes: MN1610, MN1613, MN1616 and MN1620. Lots Affected: see annex in http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2009/993_lista_produtos.pdf.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Politec Importação e Comércio 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
    993
  • Fecha
    2009-10-23
  • 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
    According to Politec Ltda, the part of the exposed sample chamber results in the inability to obtain the biopsy sample. In addition, when used in highly vascular organs, the exposed sample chamber portion can result in trauma or puncture of neighboring tissues and lead to bleeding. In most cases reported to the manufacturer of the product, there was no harm to the patient or user. The Anvisa Technovigilance Unit (UTVIG / Anvisa) is monitoring this case.
  • Causa
    Part of the sample chamber is exposed due to an extension in the length of the stylet resulting from a loose connection in the material hub.
  • Acción
    The necessary actions are as follows: (1) Check in your stock if you have affected products; (2) Segregate affected products by visually identifying them with a label; (3) Contact the product registration holder or an authorized distributor for return of the material. Distributors: - Saavedra Representações Ltda - Scientific Comércio e Importação Ltda - Radiological Products. - HPF Surgical Ltda. - Tecnomedical Medical Products. - Syncrofilm Distribuidora Ltda.

Device

BARD MAGNUM BIOCHEMICAL DISPOSABLE NEEDLE. Anvisa Registration: 10178010157. Product codes: MN161...

Manufacturer

Politec Importação e Comércio Ltda.