Events

Alerta De Seguridad para Femoral Access Cannula. ANVISA Registration No. 80219050017. Models at risk: FEMII008A, FEMII008V, FEMII010A, FEMII010V, FEMII012A and FEMII012V. Affected batches: see alert message released by the company, available in XXXXX.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por EDWARDS LIFESCIENCES LLC; Edwards Lifescience Comércio de Produtos Ltda..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1568
  • Fecha
    2015-05-05
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    The health risk assessment was assessed as moderated by the company. If the doctor attempts to insert (or use) a device that had a protruding wire, the protruding wire could damage the femoral artery, causing vascular damage that could require repair or surgical intervention. As a result, the severity of this nonconformity is Higher. According to the company, it is unlikely that this non-compliance will result in an injury, because: (1) The device is placed under direct visualization of the surgical team; and (2) Nonconformity is located near the tip of the cannula, where it is inspected and viewed routinely during insertion of the device.
  • Causa
    Presence of loose wire, located on the tip of the cannula. at the time of insertion of the device, a protruding wire could damage the femoral artery, causing vascular damage that could require repair or surgical intervention.
  • Acción
    The company is collecting the products at risk. Users of the product in question should review their entire inventory for the lots listed in the Company's Alert Message available in XXXXX. A knowledge form is included to assist you in evaluating your inventory. If you have additional inventory within your control, add the lot number and quantity in the section provided on the form. Once your inventory has been verified, complete the enclosed Knowledge Form and fax back to Edwards Customer Service at 11 5567-5313. Contact Customer Service (11 5567-5230) to obtain Return Product Authorization (RGA) number and obtain product replacement.

Device

Femoral Access Cannula. ANVISA Registration No. 80219050017. Models at risk: FEMII008A, FEMII008V...

Manufacturer

EDWARDS LIFESCIENCES LLC; Edwards Lifescience Comércio de Produtos Ltda.