Events

Safety Alert for BARDPORT TOTALLY IMPLANTABLE IN PLASTIC AND SILICONE - Registration: 10178010192 - Hazard Class: IV - MAXIMUM RISK

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; BARD ACCESS SYSTEMS.

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
    1352
  • Date
    2014-01-13
  • 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
    If the affected product is implanted in a patient, the manufacturer DOES NOT recommend removing the device. However, the final decision regarding this procedure should be at the discretion of the treating physician. ## UPDATE ON 9/1/2014 - COMPANY COMPLETED FIELD ACTION. THE PRODUCTS COLLECTED WERE DESTROYED, BY DECISION OF THE COMPANY, SINCE THAT 25 UNITS WERE REPATRIATED TO THE MANUFACTURER FOR ANALYSIS, RESEARCH AND POSTERIOR DESTRUCTION ##
  • Reason
    Silicone catheters of particular batches were identified with a size less than 5.3fr than the size of 6.6fr mentioned on the labeling of the product. annex: letter to customers.
  • Action
    Company is conducting the renegotiation of affected lots. The lots REXC0931 and REXC0736 are under threat in Brazil. ## UPDATE ON 9/1/2014 - COMPANY CONCLUDED FIELD ACTION. THE PRODUCTS COLLECTED WERE DESTROYED, BY DECISION OF THE COMPANY, SINCE THAT 25 UNITS WERE REPATRIATED TO THE MANUFACTURER FOR ANALYSIS, RESEARCH AND POSTERIOR DESTRUCTION ##

Device

BARDPORT TOTALLY IMPLANTABLE IN PLASTIC AND SILICONE - Registration: 10178010192 - Hazard Class: ...

Manufacturer

POLITEC IMPORTAÇÃO E COMÉRCIO LTDA; BARD ACCESS SYSTEMS
  • Source
    ANVSANVISA