Alerta De Seguridad para Trade name: OnControl Biopsy System Needle Trays //. Technical Name: Bone Marrow Biopsy Kit //. ANVISA registration number: 80117580255 //. Risk class: II - Medium Risk //. Affected Model: 9411 OnControl Biopsy System Needle Trays, 152MM; 9408 OnControl Biopsy System Needle Trays, 102MM //. Lots Affected: Model 9411 - OnControl Biopsy System Needle Trays, 152mm - Lots 014617, 014310, 013468, 14197 // Model 9408 - OnControl Biopsy System Needle Trays, 102mm - Lots 014569, 014308, 013257

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por EMERGO BRAZIL IMPORT IMPORTAÇÃO E DISTRIBUIÇÃO DE PRODUTOS MÉDICOS HOSPITALARES 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
    2039
  • Fecha
    2016-11-28
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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. If there are products in stock, immediately discontinue use of the product and segregate them in the quarantine and request recall. 2.To return the product, complete the recall recall form and send it to the distributor or via email recalls @ teleflex. with. This will allow you to identify the number of products in stock for return. A representative of the distributor who has carried out the commercialization of this product will contact you and guide you in the best way to return these products. 3. If you do not have any quantity of the affected product in stock, please complete the recall form, forward it to the distributor or via e-mail to recalls@teleflex.com. This will confirm that you have received this collection notice. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Causa
    Possibility of sterile packaging seal not to be completely sealed. due to compromise in packaging, sterility of the product can not be guaranteed. if sterility is compromised, there is a potential risk for infection.
  • Acción
    Field Action Code RAM 15/2016 triggered under the responsibility of EMERGO BRAZIL. Company will collect for further destruction of the product.