Events

Safety Alert for BARD TRUGUIDE COAXIAL NEEDLE FOR BIOPSY, model C2016B, registration 80689090075, hazard class II, lots: REWL0924, REXA1695, REXB1529, REXC1632.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Bard Brasil Indústria e Comércio de Produtos Médicos 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
    1819
  • Date
    2016-02-12
  • 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 potential risk associated with attempting to proceed with coaxial placement, using the sharpened stylus rather than the optional blunt tip stylus, may be variable depending on the anatomical location of the biopsy and may cause an additional unintended risk to tissue, vessels and other organs. ### UPDATED ON 10/26/2017, the company presented the completion report of the field action proving the sending of the security warning to the client with evidence of science and all actions completed.
  • Reason
    The coaxial biopsy needle may inadvertently have a blunt-tipped stylet of incorrect size that will not pass through the coaxial. specifically the product should contain a blunt tip stylus of 19 gauge and actually contains a 17 gauge stylus.
  • Action
    Gathering and destruction. Evaluate inventory and do not use or distribute any affected product. If the affected product has been safely used, no further action is required.

Device

BARD TRUGUIDE COAXIAL NEEDLE FOR BIOPSY, model C2016B, registration 80689090075, hazard class II,...

Manufacturer

Bard Brasil Indústria e Comércio de Produtos Médicos Ltda.; Bard Peripheral Vascular, Inc.