Events

CAVA OPTEASE VEHICLE FILTER SYSTEM, Optease Recoverable Cava Vein Filter Model, Registration no. 80145900717, lots: See Annex 1 - Distribution List. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    1304
  • 날짜
    2013-10-10
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    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.
  • 원인
    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.
  • 조치
    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