BD Vacutainer Glass Tubes with Vacuum Blood Collection Reagents Technical Name: BOTTLE OR MATERIAL FOR COLLECTION, STORAGE OR TRANSPORTATION OF BIOLOGICAL SAMPLES ANVISA Registration Number: 10033430467 Hazard Class: I Affected Model: VACUTAINER TUBE CITRATE .105 M TAMPA HEMOGARD 4.5 ML Serial numbers affected: Lots: 5336909; 5357632; 6,040,953; 6064634; 6124932; 6173983; 6187600 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Becton Dickinson Indústrias Cirúrgicas Ltda.; BECTON DICKINSON AND COMPANY 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
    2273
  • 날짜
    2017-04-19
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 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 letter was forwarded to customers who purchased the affected lots and advises users to: "Be sure to use Personal Protective Equipment (EPI) in accordance with instructions for use of the product, such as protective gloves and waterproof clothing, during and after The collection of any additional equipment required to ensure a safe collection, such as protective masks, should be considered; It is recommended to hold the tube while it is in the holder during collection. blood with BD Vacutainer® Push Button or BD Vacutainer® Safety-Lok ™ venipuncture safety device, the tube must be held while it is in the holder and held with the cap positioned up until the blood collection is completed. In addition, BD provided free letter service on 0800 055 5654 and e-mail consultor_vacutainer@bd.com in order to clarify any possible doubts to its customers.
  • 원인
    The bd identified an increase in the number of reports related to the occurrence of cap loosening during collection in some specific batches of vacutainer® citrate 0.0105m tubes hemogard ™ cap 4.5 ml. in this type of occurrence, the cap may remain attached to the distal needle at the disconnection of the tube at the end of the collection procedure.
  • 조치
    Field Action Code FA 18_Mar17 triggered under the responsibility of the company Becton Dickinson Indústrias Cirúrgicas Ltda. Company will communicate to the customer.