Events

BD Neoflon™ IV cannula 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Becton Dickinson 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/2013/074
  • 사례 연번
    CON322755
  • 날짜
    2013-10-10
  • 사례 출판 날짜
    2013-10-10
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON322755?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 delay in treatment due to increased risk of the catheter buckling during initial puncture of skin. due to a change in manufacturing process, the manufacturer has become aware of an increase in reported incidents of the catheter buckling in use. becton dickinson does not currently have stock available to replace affected devices. new product is being manufactured and should be available for supply from the beginning of october. becton dickinson has not issued a field safety notice in relation to this issue.
  • 조치
    Ensure staff are aware of this potential problem. Exercise additional care and vigilance when using this product and, if possible, use alternative devices until new product is available from Becton Dickinson. Report any incidents of devices buckling to the MHRA.

Device

BD Neoflon™ IV cannula
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    BD Neoflon™ IV cannula All lots of: Product code: 391350, size: 24 G, NHSSC code: FSP070 Product code: 391349, size: 26 G. This is a disposable device designed to gain access to peripheral veins of the patient’s blood system for rehydration, parenteral nutrition, medication delivery, blood transfusion and monitoring purposes.  This device is intended for use on neonatal, paediatric and geriatric patients.
  • Manufacturer
    Becton Dickinson

Manufacturer

Becton Dickinson