Events

Alerta De Seguridad para Name of the product: ANGIOGRAPHIC CATETER IMAGER II (SELECTIVE) Technical name: ANVISA registration number: 10341350453 Hazard class: IV Model affected: M001314141; M001314231; M001314321; M001314331; M001314351; M001314661; M001314671; M001315111; M001314111; M001314241; M001316871

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Boston Scientific do Brasil Ltda; Teleflex Medical.

¿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
    2198
  • Fecha
    2016-12-21
  • 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
    1. Post this information immediately in a location visible near the product to ensure that this information is easily accessible to all users of the device. The. If you identify any product in your inventory without the lower seal of the primary packaging: Discontinue use immediately and segregate the product. B. Immediately remove all affected products from your inventory. w. Segregate this product in a safe place for return to Boston Scientific. d. Immediately contact Boston Scientific to obtain a Returned Goods Authorization Number (RGA). When contacting BSC, please include your customer number, UPNs and shipment (s) affected, and quantities: Email: calidad@bsci.com 2. Complete and return the Receipt Confirmation Form. Complete the attached Receipt Confirmation Form (even if you do not already own any of the products) by following the instructions on this page and the form. Return the Receipt Confirmation Form to: Email: calidad@bsci.com
  • Causa
    Boston scientific is launching a product alert for a subset of imager ™ ii angiographic catheters. after a field report, boston scientific has determined that some units in a single batch do not have the sealing wrap inside. this was caused by an alternative label reprint process, which resulted in the absence of a step in the packaging process of the units. although boston scientific has confirmed that only one shipment has the missing seal, we are, as a precaution, notifying all customers who received shipments processed through this alternative label reprint process.
  • Acción
    Field Action Code 92042226 triggered under the responsibility of Boston Scientific do Brasil Ltda. Company will make informational to customers.

Device

Name of the product: ANGIOGRAPHIC CATETER IMAGER II (SELECTIVE) Technical name: ANVISA registrati...

Manufacturer

Boston Scientific do Brasil Ltda; Teleflex Medical
  • Source
    ANVSANVISA