Events

Infusion Pump, Injection Equipment: (1) Additive with Control Valve for Adult and 2 Injection Sites, (2) Adult Horizon with Check Valve and 3 Injection Sites, (3) Adult Injection Luer Lock Horizon, (4) Adult Injection Site Luer Lock, (5) Adult Vented Injection Site Luer Lock, (6) Adult VTND / 3 Injection / Luer Lock / Non-DEHP, (7) Basic, (8) Basic with 1 Injection Site, (9) Clave Additive Adult with Check Valve and 2 Injection Sites, (10) Primary Key / Additive / Horizon, (11) Horizon, (12) Horizon Non-DEHP Adult Vented, (13) Model AD150DS Vented 72-IN-PR, CSP152VSL W / Y Valve LT-FR-PR, (15) Model NF1250DO Universal Spike PR, (16) Model NF1270A SafeLine Anesthesia PR, (17) Model PB152VSL 105-IN-PR Model PB153VSL Non- (24) Model US3480 15-PR, (22) Model US3481 Sigma 15 Drop PR, (23) SafeLine Horizon Non-DEHP, (24) SafeSite (24) Model US1260 UltraSite, Horizon Pump, (25) UltraSite Horizon Pump. Number of Catalogs: (1) V1443; (2) V7410, V7410-10, V7412; (3) V7405; (4) V1415; (5) V1418; (6) V7430; (7) V1402; (8) V1482; (9) CC1270; (10) CC3130, CC3130-SP02; (11) NF3140, NF3140-10; (12) CC3150; (13) 351510; (14) 352049; (15) 352378, 352381, 352382, 352386, 352387; (16) 352359; (17) 351559, 351564, 352038; (18) 352072, 352127, 352131; (19) 375100, 474908; (20) 352393; (21) 352224, 352229, 352230, 352337, 352338, 352344, 352352, 352355, 352356; (22) 352362, 352363, 352365 to 352371, 352373, 352375, 352377; (23) NF3150; (24) SS3140; (25) US3130; 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 B Braun Medical Inc 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
    550
  • 날짜
    2002-03-01
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • 원인
    The philadelphia center for supply defense has issued a safety quality correction / alert for the above intravenous management teams. the above products are subject to removal due to loosening of the junction between the tube at the bottom of the container and the drip chamber. the manufacturer initiated a correction by letter dated october 2001, but did not provide any information to ecri.
  • 조치
    Make sure you have received the letter dated October 2001 from B Braun Medical. Identify and isolate any affected product in your inventory. To combine recall of the affected product, or for more information, contact your local B Braun representative. ANVISA has provided the Occurrence Notification Forms on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

Infusion Pump, Injection Equipment: (1) Additive with Control Valve for Adult and 2 Injection Sit...

Manufacturer

B Braun Medical Inc
  • Source
    ANVSANVISA