Reprocessed Agilis Steerable Introducer Sheath 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Sterilmed Inc 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
    2018-01-04
  • 사례 출판 날짜
    2018-01-04
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 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: sterilmed reprocessed agilis steerable introducer sheath the united states food and drug administration (fda) is alerting the public and health care providers that reprocessed agilis steerable introducer sheath, manufactured by sterilmed inc. the affected devices are identified as the following:- reprocessed agilis steerable introducer sheath product codes: pne; model numbers and lot numbers: stj408309, stj408310, stjg408324; all product lots; manufacturing and distribution dates: 1 january 2017 to 5 may 2017 according to the fda, the agilis steerable introducer sheath’s hemostatic valve, which prevents blood from flowing back through the valve, may fail due to an improper seal of the sheath hub. improper seals can allow blood to leak through the hub, cause the cap to fall off during the procedure, or can create a difference in pressure that allows air into the circulatory system (air embolism). the improper seal occurs when not enough glue is used to reattach the cap to the hub after reprocessing. too much glue can also block the sheath valve and make the device unusable. patients with a lower body mass index (bmi) may be more at risk if blood loss occurs. smaller patients and patients with pre-existing decreased pulmonary reserve may be more susceptible to air embolism. the use of affected products may cause serious health consequences for patients, including death. the manufacturer has provided the following instructions for health care facilities and providers: examine inventory immediately to determine if they have this product. do not use any of the affected products, and return any unused product to the company. share this information with the appropriate staff at the facility. continue to monitor patients treated with the sterilmed reprocessed agilis steerable introducer sheath as normal. for details, please refer to the fda website: https://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm590903.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 04 january 2018.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Sterilmed Reprocessed Agilis Steerable Introducer Sheath
  • Manufacturer

Manufacturer