Events

BD 60 mL syringe, Registration 10033430626 - Lot: 4232677 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.; Becton Dickinson and Company 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
    1681
  • 날짜
    2015-08-28
  • 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
    The BD informs that considering the high potential of the particles to be noticed by the health professional before the use and the improbability of being expelled, the medical evaluation concluded that the presence of particles in the BD Syringe of 60 mL LL presents a degree of risk to the patient very low. Additionally, the occurrence of an adverse event related to the 60 mL LL Syringe BD product is unlikely given the biocompatibility, very low toxicity of the product and the isolated nature of the particles.
  • 원인
    Bd received 6 customer complaints stating that white particles were present inside some 60 ml ll binding units, lot 4232677. samples were sent to the factory, which confirmed, through visual analysis, the presence of the particles in the sample. identified as being of polypropylene (the raw material constituting the syringe body). according to the investigation, the incident was caused by misalignment of the air injection sensors inside the syringe as a result of jamming in the assembly machine. the sensor misaligned as it entered the syringe body scraped the inner wall of the syringe, resulting in the presence of the particles. an additional test performed on samples from the claimed batch verified that no particles previously identified inside the syringe were expelled. we emphasize that to date, no adverse events related to this problem have been reported.
  • 조치
    The BD advises clients to take the following actions: 1. Immediately collect their inventory to identify the affected catalog and batch, segregating all units; 2. Block all available units in your stock and immediately discontinue use of the product; 3. Complete the fields of the form attached to the letter, sending the same to the email regulatory@bd.com or fax (011) 5185-9937, regardless of whether or not you still own the units affected by this action; 4. Upon confirmation of receipt of the form, the BD will contact to align the collection of the affected units and the replacement of the same. The BD is available to clarify any specific technical doubts and provide the necessary assistance through its telephone 0800 055 5654 or through the email crc@bd.com.br.

Device

BD 60 mL syringe, Registration 10033430626 - Lot: 4232677

Manufacturer

BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.; Becton Dickinson and Company