Events

Safety Alert for QUICKDRAW VENOUS CANE. Anvisa Registry n ° 80219050114. Models: QD22 and QD25. Lots under risk: 59091652, 59094887, 59222657, 59233637 and 59246684 (model QD22); 59085169, 59097289, 59352608 and 59437699 (model QD25).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Edwards Lifesciences Comércio de Produtos Médico-Cirúrgicos Ltda.; Edwards Lifescience LLC.

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
    1315
  • Date
    2013-10-22
  • 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 Edwards, the risks associated with specific product removal techniques are as follows: (1) The presence of scar tissue at the incision site can create resistance and increase the force required for removal of the cannula; (2) When the percutaneous technique is used, separation of the cannula may occur during removal if too much compression force is applied at the incision site (i.e. additional to the felt resistance if scar tissue is present).
  • Reason
    Risks associated with product-specific removal techniques quickdraw venous cannula.
  • Action
    Collection of products at risk. Identify the products in your inventory, identify and segregate them to avoid inadvertent use, and contact Edwards for product return.

Device

QUICKDRAW VENOUS CANE. Anvisa Registry n ° 80219050114. Models: QD22 and QD25. Lots under risk: 5...

Manufacturer

Edwards Lifesciences Comércio de Produtos Médico-Cirúrgicos Ltda.; Edwards Lifescience LLC