BD VACUTAINER BRAND LUER ADAPTER - Registered in Anvisa under the number 10033430348 - AFFECTED LOTS: Until May / 2013: 2051816; 2061437; 2061438; 2061448; 2061449; 2108592; 2121718; 2123785; 2123786; 2199845; 2213779; 2226823; 2263906; 2277686; 2277687; 2311696; 2311698; 2319540; 2332684; 2333888; 2342733; 3017549; 3030976. See annex: http://portal.anvisa.gov.br/wps/wcm/connect/8ce775004fbab18bb190f59a71dcc661/AnexoII_MensagemdeAlerta.pdf?MOD=AJPERES 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
    1262
  • 날짜
    2013-05-23
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 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
    BD Vacutainer Brand Luer Adapter is a noninvasive product used to attach venous access devices such as needles, scalpels and catheters to blood collection tubes. The BD through the monitoring of market complaints in the world triggered an investigative analysis associated with the function of the rubber sleeve and the luer connector. In case of leakage, the risk of exposure to blood is mitigated through the use of universal precautionary techniques. If the health professional is not adopting such techniques, there could be contact with the blood. If the blood was from a patient who is a source of pathogens, tests may be needed to rule out viral transmission and prophylaxis - in the case of HBV or HIV - with vaccines and medications. This situation associated with the occurrence rate (12.01 per 1,000,000 devices) results in an acceptable risk index. Exposure would very rarely result in viral transmission, since according to the literature this almost never occurs through exposure of non-intact skin and rarely via mucosa. Thus, the probability of acquiring a disease such as AIDS or chronic hepatitis is very low and unlikely (0.0123 per 1,000,000) and therefore the resulting risk score is acceptable. The risk of low aspiration volume in coagulation tubes is mitigated by discarding of the tube when observed leakage or by rejection of the samples collected in these tubes, since laboratory guidelines and instructions specify that collections with less than 10% of the nominal volume do not should be tested for coagulation assays. The low volume of aspiration in coagulation tubes could affect the precision of the results and possibly influence the medical analysis. In this event, the probability of a treatment being influenced is very low and unlikely (0.145 per 1,000,000) and therefore, the resulting risk score is acceptable. To date, no technical complaints or adverse events related to the product have been reported in NOTIVISA. ////// UPDATE ON 05/27/2014 - The company forwarded a form to complete this field action, ending the process of communication with customers for this security action.
  • 원인
    The gray rubber sleeve that covers the cannula inside the holder detaches itself from the cannula or allows the leaking of small amounts of blood during the multiple collection of tubes. there are also some reports that blood collection tubes may not be filled with the proper volume of blood due to damage at the tip of the luer connection. see annex: http://portal.Anvisa.Gov.Br/wps/wcm/connect/8ce775004fbab18bb190f59a71dcc661/anexoii_mensagemdealerta.Pdf?mod=ajperes.
  • 조치
    BD advised customers who purchased the product by letter to reinforce the importance of adopting universal precaution techniques to minimize the risk of blood exposure and to check for any evidence of blood leakage at the tip of the adapter luer connection. If leakage is observed, users are advised to: - discard filled tubes as they may contain lower blood volume (low aspiration), - replace the Luer adapter unit that is being used by another unit, and - continue to collect blood samples using the other unit. In addition, BD provided the free telephone service on 0800 055 5654, Ramal 9622 and e-mail consultor_vacutainer@bd.com, answered by a health professional in order to clarify any possible doubts to its clients.

Manufacturer