Events

BD PrecisionGlide Hypodermic Needle, registration no. 10033430019 - lot 9149041 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
    1619
  • 날짜
    2015-07-03
  • 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 PrecisionGlide needle is made from stainless steel, plastic resins, glue and silicone. Essentially, each of these materials is stable and must provide mechanical stability to the product even after the expiration date. The risk with the product is related to the barrier of the sterile packaging. If the package degrades after the expiration date, this may result in a breach of the sterile barrier. No reports of adverse events related to the use of this product have yet been received after expiration.
  • 원인
    In june 2015, the bd company was notified that, as a result of a mixture of lots at the warehouse of sanofi-aventis farmacêutica ltda., 5,016 units of precisionglide needle 0.60 x 25mm lot 9149041 were dispatched and delivered together with lot 3056430 . the expedition took place in june / 2015. from that same lot (lot 9149041) 3,057 needles were dispatched and delivered together with the lot. in this case the shipment occurred between january / 2013 and july / 2014. the investigation carried out by bd brasil and sanofi showed that the mixture occurred in the logistic operator of the warehouse of the company sanofi, where the lots were stored in the same pallet position and later delivered in bonus to the customers who purchased the adacel vaccine. therefore, this notice only affects healthcare institutions that eventually physically received lot 9149041 as part of the bonus linked to the acquisition of adacel (single-dose vial vaccine). lot 9149041 has expired expiration date.
  • 조치
    Some users of the Adacel Vaccine received mixed batches. So this alert and your actions are focused on this audience. Sanofi advised customers that they received the batches of PrecisionGlide Needle affected by this mix by sending a letter, directing them to take the following actions: 1. Immediately conduct the inventory survey to identify and segregate lot 9149041; 2. Do not use any unit of lot 9149041; 3. Contact Sanofi Pasteur through Telesales 0800 11 90 20 or by e-mail televendas.brasil@sanofipasteur.com

Device

BD PrecisionGlide Hypodermic Needle, registration no. 10033430019 - lot 9149041

Manufacturer

BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.