Events

Ventricular Catheter (AESCULAP ​​HYDROCEPHAL SYSTEM, Registration no. 80136990434 - lot: 4505252662 and PROGAV - GRAVITACIONAL VALVE FOR AESCULAP ​​HYDROCEPHAL, Registration 80136990624 - Serial numbers / codes Annex) 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Laboratórios B. Braun S.A. 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
    1386
  • 날짜
    2014-05-09
  • 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
    According to the manifestation of the company, the problem can occur when the surgeon moves the baffle, not being possible to do it without damaging the catheter. However, this problem is detectable by the surgeon during implantation. Thus, the risk to the patient is low and detectable. In addition, in most cases of implantation the ventricular-deflector catheter combinations are implanted without deflector movement.////// UPDATE - 07/18/2014 - The company closed the field action and the collected units were returned to the manufacturer.
  • 원인
    The company that holds the registry informs about the possibility of rupture of the ventricular catheter within the baffle. this problem may occur during implantation of the baffle, with the movement of the catheter, since the baffle attaches very strongly to the ventricular catheter. the problem is caused by deviations in the tolerance limit of the external diameter of the ventricular catheter.
  • 조치
    The company that holds the registration in Brazil requests the interruption of the distribution of said products / lots, which are still in the customer's stock, segregation thereof, information to Laboratorios B. Braun SA of the quantities of existing units of each product code and number of lot. If the aforementioned products have already been implanted, and the surgeon has noticed that signs that the Shunt is not working properly, we recommend that an investigation be done on these patients.

Device

Ventricular Catheter (AESCULAP ​​HYDROCEPHAL SYSTEM, Registration no. 80136990434 - lot: 45052526...

Manufacturer

Laboratórios B. Braun S.A.