Events

Alerte De Sécurité sur CAVA OPTEASE VEHICLE FILTER SYSTEM, Optease Recoverable Cava Vein Filter Model, Registration no. 80145900717, lots: See Annex 1 - Distribution List.

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 Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.

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
    1304
  • Date
    2013-10-10
  • 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
    The company informs that there is no impact to the patient if the physician identifies the problem and removes the filter. If there is incorrect implantation of the product with the hook oriented in the cranial direction, it can result in severe injury or risk to the patient's life, including but not limited to dissection, vessel drilling, filter migration with secondary damage to cardiac structures and ineffective prevention of pulmonary embolism. The manufacturer Cordis carried out the root cause investigation and implemented corrective actions.
  • Cause
    The company holding the record informs that manufacturer cordis has identified a printing error on an optease® retrievable vena cava filter product unit in which the femoral approach orientation arrow was printed in the wrong direction . the error resulted in the implantation of the head filter, which requires an additional percutaneous procedure to remove the filter.
  • Action
    The company is collecting the product in Brazil and guides: 1) Read the letter of Urgent Notice of Field Security. 2) Immediately identify and separate all products listed in the Distribution List (Annex I) to ensure that the affected product is not used. 3) Analyze, complete, sign and return the Confirmation Form (Annex II), according to the instructions on the form. 4) Return the affected product in accordance with the enclosed instructions, or contact your local sales representative to arrange for the return of the affected product. A credit will be provided. 5) Share this letter with everyone at your facility who needs to be informed of this recall. 6) Contact other facilities to arrange the return of OPTEASE®, if any of the indicated products has been sent there. 7) Keep this notice in mind until all the above products have been returned to the company that holds the registration. 8) Keep a copy of this notice along with the affected product. See letter to the Client (Annex III).

Device

CAVA OPTEASE VEHICLE FILTER SYSTEM, Optease Recoverable Cava Vein Filter Model, Registration no. ...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda