Events

DISPOSABLE TECHNICAL NEEDLE FOR ANESTHESIA - Registration: 10033430144, lots: 4222219 and 4217672 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Becton Dickinson Indústrias Cirúrgicas 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
    809
  • 날짜
    2005-07-27
  • 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 will arrange for the replacement of the units returned by others in accordance with the characteristic standard of the product. If you have any questions or concerns about this information, please contact your local representative or call the Customer Relationship Center at Tel.0800-555456. ANVISA will be accompanying the actions that will be carried out through the company regarding the whole process of collection and replacement of said product.
  • 원인
    Identification of less than normal luer taper.
  • 조치
    Although minor taper does not prevent the use of the product, it should be tightened properly, requiring a 90 ° rotation during the connection between the syringe and the Spinal Needle Cannula. Reviews are being conducted with the mold suppliers to ensure proper preventative maintenance of the molds. Reviews are being conducted with the mold suppliers to ensure the tests performed using the ISO caliber. The areas of Quality Assurance and Projects are developing more sensitive test to detect possible leaks.

Device

DISPOSABLE TECHNICAL NEEDLE FOR ANESTHESIA - Registration: 10033430144, lots: 4222219 and 4217672

Manufacturer

Becton Dickinson Indústrias Cirúrgicas Ltda
  • Source
    ANVSANVISA