Events

Bivona® Neonatal, Pediatric and Flextend 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/2012/002
  • 사례 연번
    CON140753
  • 날짜
    2012-01-19
  • 사례 출판 날짜
    2012-01-19
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON140753?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
    Incorrectly connected accessories may be difficult to remove, requiring excessive force to disconnect.  this may cause the tube to dislodge, requiring it to be changed. the manufacturer has initiated a recall of affected tubes. the manufacturer issued a field safety notice (fsn) – dated 15 november 2011 – but has not had confirmation from all users that they have received and acted on this information.
  • 조치
    See appendix one for affected reorder numbers, and NHS supply chain codes where applicable. Locate and quarantine all unused affected devices. Complete and return the Smiths Medical confirmation form, even if you no longer have affected units in stock. Return all unused affected devices as described in the Field Safety Notice issued by Smiths Medical. For patients with affected tubes in situ: Review the advice on correct use provided in the Customer Information Bulletin found in the FSN and the Tracheostomy – Neo-Pedi” guidance video (external link) on the Smiths Medical website.

Device

Bivona® Neonatal, Pediatric and Flextend
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Tracheostomy tubes: Bivona®  Neonatal, Pediatric and Flextend. Lot numbers from 1631477 to 1923406 inclusive. Only devices intended for neonatal and paediatric use are affected. Only tubes with an integrated connector that does not allow for use of a disconnect wedge (TR3) are affected. Examples of accessories that can be used with the affected tubes include: speaking valves, heat moisture exchangers, and breathing circuit connectors. A design modification was implemented in November 2010 to address this problem.
  • Manufacturer
    Smiths Medical

Manufacturer

Smiths Medical