Events

Reinforced endotracheal (ET) tubes – Murphy; Magill; Murphy with stylet; Magill with stylet 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Unomedical (a ConvaTec company) 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/2013/029
  • 사례 연번
    CON272226
  • 사례 출판 날짜
    2013-05-08
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON272226?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
    Potential for inadequate patient ventilation. the affected tubes may delaminate, which can lead to constriction of the lumen, resulting in a reduction of airflow to the patient. the manufacturer issued a field safety notice, dated 13 march 2013, to withdraw the affected devices but has not had confirmation from a significant number of users that they have received and acted upon this information. this alert has been issued in support of the manufacturer’s actions. delamination is the detachment of the plastic inner layers of the endotracheal tube from one another because of poor adhesion. the problem has now been rectified.
  • 조치
    Identify, quarantine and do not use affected devices. Seek alternative devices immediately. Return affected devices and the recall questionnaire to the manufacturer.

Device

Reinforced endotracheal (ET) tubes – Murphy; Magill; Murphy with stylet; Magill with stylet
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Reinforced endotracheal (ET) tubes – Murphy; Magill; Murphy with stylet; Magill with stylet. Available under three brand names: Unomedical UnoFlex TM EuromedicalTM TrachealFlex TM PharmaPlast Specific sizes and lots are affected. Reinforced endotracheal tubes are single-use medical devices comprised of an armoured, hollow cylinder inserted orally or nasally into the trachea. Pages four to six of the Field Safety Notice (FSN) provide guidance on how to identify the devices. The reference numbers and lot numbers of all the affected devices are listed on pages 10 to 38 of the FSN.
  • Manufacturer
    Unomedical (a ConvaTec company)

Manufacturer

Unomedical (a ConvaTec company)