Events

Nasogastric feeding tubes – Ryles tubes (weighted tip) 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Vygon Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert / Field Safety Notice
  • 사례 ID
    MDA/2013/009
  • 사례 연번
    CON239462
  • 날짜
    2013-02-26
  • 사례 출판 날짜
    2013-02-26
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON239462?tabName=allTabs
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • 데이터 추가 비고
  • 원인
    Risk of incorrect placement of the feeding tube due to incorrectly applied depth markings. despite issuing two field safety notices in january 2013, vygon ltd has not received sufficient confirmation from users that they have received and acted on this information.
  • 조치
    Identify and quarantine any affected devices. Ensure all users are aware of the manufacturer’s Field Safety Notices (dated 3 January 2013 and 21 January 2013). Return the confirmation requests in the FSNs to the manufacturer. If patients have affected tubes in situ, confirm correct placement before further use, following local protocols.

Device

Nasogastric feeding tubes – Ryles tubes (weighted tip)
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Nasogastric feeding tubes – Ryles tubes (weighted tip). Size 12FG 125cm, product code: 392.12, lot number: 160412FG. Size 14FG 125cm, product code: 392.14, lot number: 100512FF. The affected product codes on the manufacturer’s website and device labels are specified as ‘392.12’ and ‘392.14‘.  The same products are referred to as ‘0392.12’ and ‘0392.14’ respectively in the manufacturer’s Field Safety Notices.
  • Manufacturer
    Vygon Ltd

Manufacturer

Vygon Ltd