Events

Trade name: BD Eclipse Safety needle / BD Eclipse Hypodermic Needle with Safety Device / BD Eclipse Needle Gasometer Syringe Technical Name: Disposable Needles and Disposable Syringe ANVISA Registration Number: 10033430591/10033430694/10033430689 Hazard Class: II Model Affected : 302811/302812/302813/302814/302815/302816/302817/302818/30281364/364390/364391/365059/365061 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
    2066
  • 날짜
    2017-01-20
  • 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
    BD Brasil will send letters to direct customers (hospitals and laboratories) and distributors who have purchased the affected needles sold since January 2015, reaffirming the need to follow the instructions correctly: In compliance with the strategy adopted by the legal manufacturer (BD EUA) "Center your thumb or index finger on the wider area of ​​the textured digital pad and push the safety device over the needle until you hear or feel it is locked. Visually confirm that the needle is covered. "The product may continue to be used observing the guidelines described in the instructions for use.
  • 원인
    Bd brasil will send letters to direct customers (hospitals and laboratories) and distributors who have purchased the affected needles sold since january 2015, reaffirming the need to follow the instructions correctly: in compliance with the strategy adopted by the legal manufacturer (bd eua) "center your thumb or index finger on the wider area of ​​the textured digital pad and push the safety device over the needle until you hear or feel it is locked. visually confirm that the needle is covered. "the product may continue to be used observing the guidelines described in the instructions for use.
  • 조치
    Field Action Code FA 07_Dez17 triggered under the responsibility of the company Becton Dickinson Indústrias Cirúrgicas Ltda. Company will notify the customer.

Device

Trade name: BD Eclipse Safety needle / BD Eclipse Hypodermic Needle with Safety Device / BD Eclip...

Manufacturer

Becton Dickinson Indústrias Cirúrgicas Ltda
  • Source
    ANVSANVISA