Events

Insyte AutoGuard Intravenous Catheters; In the Catalog. (1) 381412, (2) 381423, (3) 381433, (4) 381434, (5) 381437, (6) 381444, (7) 381447, (8) 381454, (9) (11) 381523, (12) 381533, (13) 381534, (14) 381544; 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 BD Infusion Therapy Systems 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
    179
  • 날짜
    2000-02-24
  • 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
    BRAZIL-21.12.2001. The company reports that on September 18, 2001, Becton Dickinson & company; through its BD medical systens division, notified the FDA that it had identified through its own controls that batches 106170 and 108010 of the catheter insyte autoguard product, manufactured in its the sandy, utah-usa plant had micro-holes in the primary packaging. In order to prevent potential risks of adverse effects, the company voluntarily decided to collect these lots from the market. He also reports that no notification was sent to foreign governments by Becto Dickison's subsidiary due to the fact that the product was exclusively distributed on the American market.
  • 원인
    Lots nos .: (1) 909170, 910152, 910171, 911151, 911164, 912160; (2) 909166, 909169, 909179, 909172, 909172, 909172, 909181, 910153, 910163, 910163, 910170, 910172, 910175, 910180, 910186, 911187, 911167, 911161, 911163, 911166, 911173, 911177, 912153, 912155, 912158, 912161 , 912165, 912174, 912180, 912183, 001152, 001157, 001163, 001171; (3) 909173, 910151, 910154, 911158, 912151, 912167; (4) 907176, 907177, 908166, 908175, 908176, 909152, 909165, 910157, 910173, 910177, 910182, 911153, 911154, 911169, 911172, 911182, 911185, 912156, 912164, 912166, 912171, 912173, 912176, 912182 , 001151, 001158, 001170; (5) 911176; (6) 909178, 910162, 910164, 910174, 910176, 910179, 911156, 911159, 911165, 911178, 911180, 912152, 912159, 912162, 912169, 912177, 001153, 001159, 001164, 001172; (7) 910169, 912172; (8) 910156; (9) 910167; (10) 910166, 910178, 911168, 911175, 912168; (11) 908177, 910161, 910183, 911179, 912154, 912185, 001162; (12) 910181, 911152, 912157; (13) 908172, 909179, 910165, 911155, 911170, 912179, 001160; (14) 910184, 911171, 912175 the mentioned catheters may cause epithelial irritation at the catheter insertion sites. the manufacturer initiated a mail-order and visit removal, shipped on february 23 and 24, 2000.
  • 조치
    Make sure that you have been contacted by BD Infusion Therapy Systems. Identify and isolate any affected product from your inventory. Contact BD Infusion Therapy Systems at the address listed to make arrangements for returning the product and obtaining the replacement product. For more information, contact your local BD representative or Rand Pugmire, recall coordinator, at (801) 565-2550 in the United States.

Device

Insyte AutoGuard Intravenous Catheters; In the Catalog. (1) 381412, (2) 381423, (3) 381433, (4) 3...

Manufacturer

BD Infusion Therapy Systems
  • Source
    ANVSANVISA