Events

BD Plastipak Hypodermic Syringe without Needle 20mL registration no. 10033430030 - Lots - 4161132 and 4227147 - Client List - Attachment 1 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
    1613
  • 날짜
    2015-06-19
  • 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
    According to the risk assessment performed by the BD Medical Department, the health risk was classified as limited severity and unlikely occurrence, resulting in a low health risk index (green zone). This classification of severity and occurrence indicates that this defect is unlikely to trigger the need for medical or surgical intervention in order to prevent permanent impairment of a function or structure of the organism. The medical evaluation concluded that the partially opened sealing defect in the 20 mL syringe has the potential of being noticed by the health care professional before use and the syringe being discarded. If open sealing is not noticed and the syringe is used to prepare medication, it is unlikely that any microorganism has migrated to the fluid path. In addition, considering that a sterile needle must be attached to the syringe for aspiration procedures of blood or body fluids there is no health risk in these procedures when performed with this product.
  • 원인
    Bd received a customer complaint stating that some units of lot 4161132 had the packaging open. samples were sent to the manufacturer for evaluation, which confirmed that the packages were partially opened in the sealing area. an investigation was initiated and identified that the batch was produced with the forming temperature outside the one specified in the validation, which may lead to the occurrence of the partially open sealing defect. this defect impacts the integrity of the package and can potentially affect the sterility of the product. during the verification of the comprehensiveness of the situation, it was identified that lot 4227147 was also manufactured at a temperature outside the specified range. although the bd received no complaints and had not found any open sealed unit for lot 4227147 during the investigation, it was still decided to start the recall procedure for the two batches. the company informs that to date, no adverse events related to this product have been registered.
  • 조치
    BD has communicated the clients affected by this field action by sending a letter, which directs them to take the following actions: 1. Immediately survey their inventory to identify the catalog and batches affected, 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 it to regulatorio@bd.com or fax (011) 5185-9937, regardless of whether or not you still own the units affected by this action. For more information, see Annex II - Customer Notice.

Device

BD Plastipak Hypodermic Syringe without Needle 20mL registration no. 10033430030 - Lots - 4161132...

Manufacturer

BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.