Events

CATEGORY ANGIOGRÁFICO IMAGER II - Registered in Anvisa under the number 10341350453 - Lots - see attached list. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Boston Scientific do Brasil 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
    1000
  • 날짜
    2010-01-08
  • 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
    Boston Scientific is aware that hospitals often remove the product from their outer carton and store it on the stock shelves only in their pouch. If this is a practice in your unit, it is very important that when searching for affected / collected product, you carefully use the enclosed product table, taking into account both the UPN code of the product in the inner and outer carton. Anvisa has no reports of adverse events or technical complaints regarding this problem to date. #### Update: Boston Scientific do Brasil Ltda informed the UTVIG / ANVISA about the closure of the field action related to this alert, on January 19, 2011. According to the company, 18 units of the product were collected from a total of 120 units under risk marketed in Brazil.
  • 원인
    Boston scientific has identified that for the affected products, the sterile closure of the pouch containing the catheter may be broken. the breach of sterility may lead to contamination of the device, with transfer of infectious agents to the patient. as of october 5, 2009, boston scientific has received three complaints in the united states reporting this problem with the packaging of the angiographic imager ii catheter. boston scientific is not aware of any complications to the patient resulting from this problem.
  • 조치
    The Verification and Traceability Response Form included in this Voluntary Customer Grievance Notice must be completed and returned, even if you do not have any of the units for the voluntary recall codes and lots. 1. Immediately discontinue use and segregate all products from voluntary gathering. • Immediately remove all products from the affected voluntary recall of your inventory (either at the Radiology Department, Catheter Lab, Central Service, Shipment and Receipt or elsewhere). • Isolate this product in a safe area for return to Boston Scientific. 2. Complete and return the Verification and Traceability Response Form. • Complete the attached Verification and Traceability Response Form (even if you do not have a product to return) by following the instructions on this page and the Verification and Traceability Response Form. • Return the Verification and Traceability Response Form by fax to: Boston Scientific do Brasil Ltda. A / C: Dalton Nivoloni Fax: (11) 5502-8510 - e-mail: dalton.nivoloni@bsci.com Please fax your Form (s) for Verification and Traceability Response immediately. product, attach the original form. 3. Pack / ship the product of the Voluntary Retreat. • Pack the products to be returned in an appropriate box. • Identify the box with the customer's name. • Ask for the collection by calling (11) 5502-8583, with Danielle Almeida.

Device

CATEGORY ANGIOGRÁFICO IMAGER II - Registered in Anvisa under the number 10341350453 - Lots - see ...

Manufacturer

Boston Scientific do Brasil Ltda.
  • Source
    ANVSANVISA