Alerta De Seguridad para Commercial Name: Hemostatic Clip. Technical Name: Clamp. ANVISA registration number: 10175069002. Class of risk: II. Affected Model: 479201: Introducing Cannula: 20 G x 9 cm; Length of the thread: 20 cm; Distance: 11.3 cm. Affected serial numbers: Of all lots involved, only one was imported into Brazil: REZL0066

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Bard Brasil Indústria e Comércio de Produtos Medicos Ltda; Bard Reynosa S.A. de C.V./Bard Peripheral Vascular, Inc.

¿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
    If the affected product has been safely used, then no further action is required. 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 - Date of identification of the problem by the company: 03/28/2017 - Date of notification notice to Anvisa: 04/07/2017 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. (...) "#### UPDATED ON 08/17/2017, the company sent the completion report of the field action proving the accomplishment of correction as planned.
  • Causa
    Between the dates of july 20 and november 7, 2016, 5 complaints were received alleging magnetic resonance artifact caused by the wire locating to rm ghiatas. no lesions have been reported in the patient. through further investigation, it was confirmed that some rm ghiatas wire packages contained non-rm compatible ghiatas wires made of t304 stainless steel instead of wires for rm ghiatas made with 625 inconel. in mri, the use of a non-rm locating wire instead of an mr-compatible locating wire would create an image artifact. the mri artifact allegedly caused by the mama ghiatas localization wires may be associated with a varying degree of physician dissatisfaction as well as harm to the patient. the presence of an artifact on mri is undesirable and may potentially have serious clinical implications. however, regarding the placement and use of locating wire, there are other viable means to ensure that the intent of the wire, which is to take the surgeon to the area of ​​injury, can still be achieved with a high level of success.
  • Acción
    Field Action Code No code triggered under the responsibility of the company Bard Brasil Indústria e Comércio de Produtos Medicos Ltda. It will collect and destroy the product.