Events

Entrada Needle (Accessory Infinion CX lead) 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Boston Scientific 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
  • 날짜
    2018-04-12
  • 사례 출판 날짜
    2018-04-12
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180412b.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: entrada needle (accessory infinion cx lead) medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its entrada needle (accessory infinion cx lead). the affected devices are identified as the following: - product description: a) entrada 2.0 4.5” needle kit; b) entrada 2.0 6” needle kit; c) entrada 2.0 4.5” spare sheath kit; d) entrada 2.0 6” spare sheath kit universal product number: a) m365sc4220450; b) m365sc4220600; c) m365sc4220s450; d) m365sc4220s600 brand name: infinion cx lead approval number: 22700bzx00348000 the manufacturer has detected some products did not meet the acceptance criteria during a needle resistance loss leakage test in the accelerated 2 years aging test which was performed for an additional manufacturing site. therefore, the manufacturer is initiating voluntary removal of the products in japanese market. according to the manufacturer, if there is leakage of the products, the operator may not be able to feel sufficient resistance. this could potentially result in prolonged procedure and may puncture the spinal cord beyond the epidural space as severe health impact. however, as it is recommended that this procedure to be performed under x-ray fluoroscopy in the instruction, a severe health impact would not occur. while the product is currently being sold worldwide, there have been no complaints related to this event. the users are recommended to return unused removal products and not to use the affected products. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 april 2018.

Device

Entrada Needle (Accessory Infinion CX lead)
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: "Entrada Needle (Accessory Infinion CX lead)"
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH