Events

Central Venous Catheters: Multicath Expert 5 Lumen (9.5FG/16cm) 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 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/2014/045
  • 사례 연번
    CON482907
  • 날짜
    2014-12-05
  • 사례 출판 날짜
    2014-12-05
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON482907?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 catheter and delay to treatment. this is due to a manufacturing problem resulting in: decreased length of the catheter. the catheter tip may not reach the desired position during placement. catheters with four lumens (instead of five). this may then require additional catheter or extension sets after placement. vygon has issued a field safety notice (fsn), dated 16 september 2014, to its customers recalling affected catheters but has not received enough replies to assure themselves that users have received and acted on this information.
  • 조치
    Identify and quarantine affected catheters. Complete the confirmation form in the FSN to arrange for replacement catheters if necessary. Return the form to the manufacturer. All those responsible for the purchase and use of this device.

Device

Central Venous Catheters: Multicath Expert 5 Lumen (9.5FG/16cm)
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Central Venous Catheters: Multicath Expert 5 Lumen (9.5FG/16cm). Product Code: 8159.167 Lot/Batch number: 020414GE If relevant to you, the national supply codes are as follows: England NPC: FSU144 . Northern Ireland: Device supplied by PaLS as a 'Non Stock Item' Scotland SKU: NP106/12 Wales NSV: FSX0677
  • Manufacturer
    Vygon

Manufacturer

Vygon