Events

Alerte De Sécurité sur 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

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Bard Brasil Indústria e Comércio de Produtos Medicos Ltda; Bard Reynosa S.A. de C.V./Bard Peripheral Vascular, Inc.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    2350
  • Date
    2017-04-07
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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.
  • Action
    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.

Device

Commercial Name: Hemostatic Clip. Technical Name: Clamp. ANVISA registration number: 10175069002....

Manufacturer

Bard Brasil Indústria e Comércio de Produtos Medicos Ltda; Bard Reynosa S.A. de C.V./Bard Periphe...