Events

Safety Alert for Temporary Vein Vein Filter TEMPOFILTER II. Regista Anvisa n. Affected lots: all lots, as of January 1, 2006.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by LABORATÓRIOS BBRAUN SA..

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
    1056
  • Date
    2011-04-26
  • 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 BBRAUN, the action was taken due to the report of five cases of stem fracture worldwide and there is no report, so far, of adverse events resulting from the problem in question. The migration of the fractured stem would be the main risk for the patient. For more information, consult http://portal.anvisa.gov.br/wps/wcm/connect/11bfe68046a41c38bc30bdc9c474c85c/Carta+Informativa.pdf?MOD=AJPERES.####ATUALIZAÇÃO - 12/13/2011 - The company forwards field action completion report. Of the 41 units sold, 21 were collected and returned to the manufacturer. Corrective measures have been taken provided greater resistance to rupture. ####
  • Reason
    Possibility of breaking the stem of the implantable product.
  • Action
    The BBRAUN company has already started collecting the product. Health facilities should IMMEDIATELY discontinue use of the product by removing them from the stock and segregating them properly so that they are not inadvertently used. The segregated products should be sent to the distributor, following guidelines of the company BBRAUN. Products already implanted should be removed if the indication of the vena cava filter is no longer justified and, at most, at the end of the tenth week. According to the company, IT IS OF FUNDAMENTAL IMPORTANCE THAT THE FILTER BE REMOVED BEFORE THE END OF THE TWENTY-SECOND WEEK AFTER DEPLOYING THE DEVICE.

Device

Temporary Vein Vein Filter TEMPOFILTER II. Regista Anvisa n. Affected lots: all lots, as of Janua...

Manufacturer

LABORATÓRIOS BBRAUN SA.