Events

Safety Alert for Trade name: WIRES FOR LOCATION OF INJURY IN THE BARD DUALOK SEALS - Registration: 10178010188 - Hazard Class: II - MEDICAL RISK - Technical Name: Wire Guide - Affected Models: LW0037; LW0057; LW0077; LW0107; LW0137 - Affected lots: SEE List of affected lots and distribution map (IN ANNEX)

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 Peripheral Vascular, Inc..

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
    1420
  • Date
    2014-09-09
  • 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 the company Politec Importação e Comércio Ltda., "It is advisable to closely monitor patients who are known to have been treated using these affected location wires and are still at risk of developing infectious complications. responsible doctor. "
  • Reason
    The bard dualok seal injury wire may inadvertently penetrate / puncture / cut off its original packaging, thus breaking its sterility barrier and bringing the product into contact with the outside of the packaging. the problem described may increase the risk of injury, including complications associated with localized or systemic infections, which may require medical intervention to prevent serious injury.
  • Action
    Company will make the collection and return it to the manufacturer, located in the United States. Code 170/2014.

Device

Trade name: WIRES FOR LOCATION OF INJURY IN THE BARD DUALOK SEALS - Registration: 10178010188 - H...

Manufacturer

Politec Importação e Comércio Ltda.; Bard Peripheral Vascular, Inc.
  • Source
    ANVSANVISA