Alerta De Seguridad para Identification of the product or case :. Trade Name: BD Posiflush Heparin Lock Flush Syringe. Technical Name: Disposable Syringes. Registration number ANVISA: 10033430366. Class of Risk: IV. Affected model: BD Posiflush Syringe with Heparin, USP, 300 units / 3mL (100 units / mL) - 3mL in 10mL syringe. Serial numbers affected: Lots #: 708782N and 709772N.

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; Becton, Dickinson and Company.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • 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
    The following steps should be taken: 1. Check immediately if you still have the catalog and batch (s) in your inventory. If you have units in stock, discontinue and segregate them. 2. Share this notification with any other users of this product at your institution to make sure everyone is aware. 3. Complete the form attached to the letter to the customers, stating whether or not you have any affected product, and send the e-mail, so that the company becomes aware of the receipt of this notification. Proceed with the collection and replacement of the products, if you still have units of the lots informed. 4. Notify the company and ANVISA of any adverse events that occurred, related to the situation described in this notification. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa / notivisa). 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 Complementary Information: - Date of identification of the problem by the company: 04/23/2018 - Date of notification notice to Anvisa: 05/16/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: (...) Art. 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...)
  • Causa
    In an investigation conducted by the us fda in relation to patients infected by the bacterium serratia marcescens in the united states of america, it was identified that the patients involved underwent treatments that included, in addition to other products, the use of bd posiflush syringe with heparin . this is a suspicion not yet confirmed. the company is carrying out the collection of the products and anvisa is monitoring the action.
  • Acción
    Field Action Code 24_Abr18 under the responsibility of the company Becton Dickinson Indústrias Cirúrgicas Ltda. Gathering.