Events

Portex® endotracheal tube holder (2.5mm and 3.0mm) sold as stand-alone products or packaged in intubation kits 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Smiths Medical 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/2014/036
  • 사례 연번
    CON456001
  • 날짜
    2014-09-17
  • 사례 출판 날짜
    2014-09-17
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON456001?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 extubation or delay to therapy as there may be difficulty passing a suction catheter through the endotracheal tube when the holder is locked. there may also be difficulty locking the holder. this is due to a manufacturing problem, which means the holder might compress the endotracheal tube. smiths medical has issued a field safety notice (fsn) recalling affected devices but hasn’t had sufficient confirmation that customers have received it and acted on it.
  • 조치
    Identify affected devices as described in the FSN and quarantine them. Complete and return the confirmation form in the FSN. Arrange for replacement devices with Smiths Medical.

Device

Portex® endotracheal tube holder (2.5mm and 3.0mm) sold as stand-alone products or packaged in in...
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Portex® endotracheal tube holder (2.5mm and 3.0mm) sold as stand-alone products or packaged in intubation kits. Specific product codes and lot numbers. If relevant to you, the national supply codes are as follows: Scotland SKU: Smiths code NDC code H4001PS 054220 H4001S 007424 H4002PS 014408 H4002S 039364 H4051 - H4052 - England NPC: use manufacturer’s codes in the FSN Northern Ireland: use manufacturer’s codes in the FSN Wales NSV: use manufacturer’s codes in the FSN
  • Manufacturer
    Smiths Medical

Manufacturer

Smiths Medical