Events

VenaSeal Closure System Model SP-101 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Medtronic 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
    2015-05-04
  • 사례 출판 날짜
    2015-05-04
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150504.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: medtronic venaseal closure system model sp-101 medical device manufacturer, medtronic, has issued a medical device safety alert concerning all former sapheon (covidien) venasea closure systems model sp-101. the manufacturer is conducting a voluntary recall of all former sapheon (covidien) venaseal closure systems due to potential for sterility breach of the outer packaging (pouch) material. a breach of the outer pouch may compromise the outside surface sterility of the sealed inner tray which does not directly affect the sterility of the device components. the manufacturer has received one complaint potentially related to this issue resulting in an occurrence rate of 0.0253%. this complaint is associated with a serious patient injury; however it is unclear if this injury is device related. there have been no reports of death related to this issue. according to the manufacturer, the breach in the pouch barrier may not be detectable by visual inspection of the product. while the device components within the sealed inner tray are not directly affected by this issue, the introduction of a non-sterile inner tray (outer surface of the inner tray contaminated) could potentially contaminate the sterile field and sterile personnel, thereby creating a possible indirect pathway for microbes to come in contact with the patient, which may cause an infection. if a patient has received treatment with a venaseal closure system, no action is required and patients should continue to be monitored in accordance with standard of care. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 may 2015.

Device

VenaSeal Closure System Model SP-101
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Medtronic VenaSeal Closure System Model SP-101
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH