Events

BD EXACTA - INTRODUCTORY KIT OF ARTERIAPULMONAR CATETER - Registration: 10033430274 - Lots: 309420/406463/311610/311609/311197/406462 /. 311612/309419/309418/380187/406374 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
    807
  • 날짜
    2005-05-13
  • 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
    It is important that the following actions are taken: 1. Identify whether you are using or have stock of the products according to the batches indicated; 2. Discontinue use immediately and block stock; This product will be collected and replaced by your distributor; 3. Complete the Fonnary sent by the company; 4. Return the completed form to the BD, through your distributor or by fax (11) 5185.9642 (BD). If you have any questions or concerns about this information, please contact your local representative or call the Customer Relationship Center at Tel.0800-655654. 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. xxxxx The company informs the closing of the collection process, that is, all existing material in the Brazilian Market was collected and replaced.
  • 원인
    Bd singapore (manufacturer) received 4 entries that the sealing of the primary packaging (tray versus cap) was incomplete, which could compromise the sterility of the product. it has been reported that bd singapore has not received any reports of increased infection rate related to the use of these products during the last 5 years. however the evaluation of the manufacturing process identified a failure during packaging and, as a precautionary measure, the manufacturer is collecting all kits that were marketed after 1999, the date the current sealing process was implemented.
  • 조치
    BD Singapore is reviewing the sealing process in order to correct the flaw. In the meantime, the visual inspection of 100% of the units was introduced in the manufacturing and packaging process. In Brazil Although no adverse events have been reported with the use of any unit of these batches, BD requests that the use of the product BD EXACTA - CATTERY INTRODUCTOR KIT OF ARTERIAPULMONAR - Registration: 10033430274 - Lots: 309420/406463/311610/311609 / 311197/406462 / 311612/309419/309418/380187/406374 is interrupted and the drives are returned. The company will arrange for the replacement of units returned by others in accordance with the kit's characteristic standard.

Device

BD EXACTA - INTRODUCTORY KIT OF ARTERIAPULMONAR CATETER - Registration: 10033430274 - Lots: 30942...

Manufacturer

Becton Dickinson Indústrias Cirúrgicas Ltda.
  • Source
    ANVSANVISA