Events

Safety Alert for Trade name: Accessories for Liquor System ###. Technical Name: Infusion Port Catheter ###. ANVISA registration number: 10175060023 ###. Risk Class: IV (Maximum Risk) ###. Affected Model: ###. Batch numbers affected: AUTO087510 / 515, AUTO084109 / 240, AUTO088695 / 635, AUTO087642 / 526, AUTO088287 / 589, AUTO087772 / 561, AUTO088695 / 632

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Ventura Biomédica 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
    1977
  • Date
    2016-08-19
  • 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
    The company emphasizes that there is no need for additional recommendations beyond those contained in the Instructions for Use of the product once the technical, manufacturing and validity characteristics of the product have been maintained. The measure taken by the company was the immediate blocking of sales and recall of the product as soon as it was found that the registration of the product had expired. 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
  • Reason
    The company missed the deadline for revalidation of registered product registration under the number 10175060023. therefore, it decided to include the product "accessories for liquor system" (record 10175060023) in the product register "synchrony-cello series hydrocephalus valve" anvisa 10175060021), whose process has not yet been approved by anvisa (protocol 25352876203201622).
  • Action
    Field Action No. 186/16 triggered under the responsibility of Ventura Biomédica Ltda. Company is promoting the recall of the products that are in the market.

Device

Trade name: Accessories for Liquor System ###. Technical Name: Infusion Port Catheter ###. ANVISA...

Manufacturer

Ventura Biomédica Ltda.