Events

Broviac Paediatric Catheter 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 Becton, Dickinson and 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
    Field Safety Notice
  • 사례 연번
    SN2003(01)
  • 날짜
    2003-02-13
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/broviac-paediatric-catheter&id=fc91f825-9782-6eee-9b55-ff00008c97d0
  • 비고 / 경고
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • 데이터 추가 비고
  • 원인
    The imb has been advised of several incidents with patients on long-term total parenteral nutrition using a broviac paediatric catheter.  defects developed at a similar point on the catheter, where the hub separated from the catheter.
  • 조치
    The IMB advise that users of this product:  Ensure that all staff dealing with broviac lines are advised of the incidents that have arisen with this device.   Advise all staff and family members dealing with the device to carry out regular inspections of the device.   Ensure that all staff and family members are trained in the use of the catheter. Ensure the device is clamped at the points indicated by the manufacturer in their literature.   Report any indication of problems with the device to the Irish Medicines Board

Device

Broviac Paediatric Catheter

Manufacturer

Becton, Dickinson and Company