Events

Safety Alert for Implanted Infusion Device with Multi-Dose Reservoir /// Technical Name: Catheter with Infusion Port /// ANVISA Registration Number: 10175060017 /// Risk Class: IV - Maximum Risk /// Model Affected: 09039303 - Sectional Implanted Infusion Device with Multi-Dose Reservoir Affected Lot Numbers: See Distribution Map

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
    1990
  • Date
    2016-08-30
  • 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
    Suspend the marketing and use of the product. Products remaining on the market should be segregated and returned to the manufacturer. ## UPDATE # Field action closure: 12/12/2016. According to the report sent by the company, the products collected from customers and those that were in the company's stock were decharacterized. ### UPDATED ON 8/16/2017. The reason for the notification was discontinuation of the manufacture of regularized product. This situation does not constitute a motivation for field action, under the terms of RDC No. 23/2012.
  • Reason
    Cancellation of the registration of the product with anvisa, since ventura biomédica chose to discontinue its manufacture.
  • Action
    Field Action Code FNC 216-2016 triggered under the responsibility of Ventura Biomédica Ltda. Company is performing collection of the remaining products on the market.

Device

Implanted Infusion Device with Multi-Dose Reservoir /// Technical Name: Catheter with Infusion Po...

Manufacturer

Ventura Biomédica Ltda.