Events

CATETER BD HYDROCATH 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 BECTON DICKISON 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
    90
  • 날짜
    2001-10-11
  • 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
    BRAZIL - 11/10/2001 - INFORMS THAT PROTOCOLED TO ANVISA-NATIONAL AGENCY OF SANITARY SURVEILLANCE - BRAZIL, (PROTOCOL No. 123660/11) REQUEST FOR AMENDMENT OF PRODUCT NAME FOR BD CATHETER INTRAVENOUS CENTRAL HYDROCATH AND ACCESSORIES. ALTERATION OF LABELING: "AGAINST INDICATION - DO NOT USE IN DIFFERENT PEDIATRICS SUSPECTING IMMEDIATE REACTIONS OF TYPE HYPENSENSILITY, THE INTRAVENOUS CATHETER BD HYDROCATH SHOULD NOT BE USED IN PATIENTS WITH A WEIGHT BELOW 20 KG WARNING - HAS BEEN SUSPECTED OF CASES ISOLATED OF TYPICAL REACTIONS HYPERSENSITIVITY IN PATIENTS TREATED WITH BD HYDROCATH INTRAVENOUS CATHETER: AS A PRECAUTIONARY MEASURE, THE POSSIBILITY OF THE OCCURRENCE OF SUCH REACTIONS SHOULD BE CONSIDERED WHEN USING THIS CATHETER "
  • 원인
    Occurrence of rare cases of immediate types of hypersensitivity reactions during the use of bd hydrocath central and arterial cathederes - 1 reaction / 60,000 catheters, 80% of which is verified in pediatric cases.
  • 조치
    CONSIDERING THE SUSPECTED INCIDENT, THE COMPANY HAS DECIDED TEMPORARILY TO SUSPEND THE MARKETING OF CATHETER HYDROCATH IN ALL COUNTRIES WHERE IT DID BUSINESS WHERE THAT ANALYTICAL TESTS AND RISK ASSESSMENT LEADED BY EXPERTS FROM THE HEALTH AREA OF GERMANY AND ENGLAND SEARCH THE EXISTENCE OF A RELATIONSHIP OF CASUALITY BETWEEN THE INCIDENT AND THE DEVICE. IT ALSO REPORTS, THAT BY PRECAUTION, ALERTED THE MEDICAL COMMUNITY, THROUGH * NOTICE INSERTED IN THE PACKAGE AND PROTOCOL TO ANVISA-NATIONAL AGENCY OF SANITARY SURVEILLANCE- BRAZIL, REQUEST OF ALTERATION OF LABELING. WITH THE FOLLOWING INFORMATION: * "AGAINST INDICATION - DO NOT USE IN DIFFERENT PEDIATRICS SUSPECTED OF IMMEDIATE REACTIONS OF THE TYPE HYPENSENSILITY, THE INTRAVENOUS CATHETER BD HYDROCATH SHOULD NOT BE USED IN PATIENTS WITH A WEIGHT BELOW 20 KILOS WARNING - HAS BEEN SUSPECTED OF CASES ISOLATED OF REACTIONS OF THE TYPE HYPERSENSITIVITY IN PATIENTS TREATED WITH INTRAVENOUS CATHETER BD HYDROCATH. AS A PRECAUTIONARY MEASURE, THE POSSIBILITY OF THE OCCURRENCE OF SUCH REACTIONS SHOULD BE CONSIDERED WHEN USING THIS CATHETER "

Device

CATETER BD HYDROCATH

Manufacturer

BECTON DICKISON
  • Source
    ANVSANVISA