Events

Alerta De Seguridad para Trade name: BD Eclipse Safety needle / BD Eclipse Hypodermic Needle with Safety Device / BD Eclipse Needle Gasometer Syringe Technical Name: Disposable Needles and Disposable Syringe ANVISA Registration Number: 10033430591/10033430694/10033430689 Hazard Class: II Model Affected : 302811/302812/302813/302814/302815/302816/302817/302818/30281364/364390/364391/365059/365061

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Becton Dickinson Indústrias Cirúrgicas 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
    2066
  • Fecha
    2017-01-20
  • 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
    BD Brasil will send letters to direct customers (hospitals and laboratories) and distributors who have purchased the affected needles sold since January 2015, reaffirming the need to follow the instructions correctly: In compliance with the strategy adopted by the legal manufacturer (BD EUA) "Center your thumb or index finger on the wider area of ​​the textured digital pad and push the safety device over the needle until you hear or feel it is locked. Visually confirm that the needle is covered. "The product may continue to be used observing the guidelines described in the instructions for use.
  • Causa
    Bd brasil will send letters to direct customers (hospitals and laboratories) and distributors who have purchased the affected needles sold since january 2015, reaffirming the need to follow the instructions correctly: in compliance with the strategy adopted by the legal manufacturer (bd eua) "center your thumb or index finger on the wider area of ​​the textured digital pad and push the safety device over the needle until you hear or feel it is locked. visually confirm that the needle is covered. "the product may continue to be used observing the guidelines described in the instructions for use.
  • Acción
    Field Action Code FA 07_Dez17 triggered under the responsibility of the company Becton Dickinson Indústrias Cirúrgicas Ltda. Company will notify the customer.

Device

Trade name: BD Eclipse Safety needle / BD Eclipse Hypodermic Needle with Safety Device / BD Eclip...

Manufacturer

Becton Dickinson Indústrias Cirúrgicas Ltda
  • Source
    ANVSANVISA