Events

Safety Alert for 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.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Politec Importação e Comércio Ltda..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    993
  • Date
    2009-10-23
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the 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.
  • Reason
    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.
  • Action
    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.