Events

Hudson RCI nebulizer adaptors and Aquapak sterile water with nebulizer adaptors 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Teleflex 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/2014/042
  • 사례 연번
    CON471141
  • 날짜
    2014-11-03
  • 사례 출판 날짜
    2014-11-03
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON471141?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
    The packaging of these devices might not be sealed properly. however, the adaptors are used as part of a non-sterile system, so there is minimal risk of infection to patients. teleflex sent an amended field safety notice (dated 19 september 2014) to its customers recalling affected products but hasn’t had enough replies to know that users have received and acted on this information.
  • 조치
    Identify and quarantine the affected devices using the codes in the FSN. Return affected devices and arrange for replacements from Teleflex. Return the acknowledgement form to the manufacturer.

Device

Hudson RCI nebulizer adaptors and Aquapak sterile water with nebulizer adaptors
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Hudson RCI © nebulizer adaptors and Aquapak sterile water with nebulizer adaptors. Specific product and lot numbers. Check Appendix 2 of the FSN for the full list of affected product codes. If relevant to you, the national supply codes are as follows: England NPC: NHS Supply chain code Manufacturer’s part number Product description FDE115 4044-28 AQUAPAK 428 SW,440 ML W/028 ADAPTOR,INTL FDE130 403128 ADAPTOR,028 NEB,INTL FDE369 403728 AQUAPAK 728 SW,760 ML W/028 ADAPTOR,INTL FDE384 404128 AQUAPAK 1028 SW,1070 ML W/028 ADAPTOR,IN Northern Ireland: The products identified in the FSN are not on regional contract within Northern Ireland but may have been acquired as non-stock items. Scotland SKU: Supply chain code Manufacturer’s part number Product description 031498 403128 ADAPTOR, 028 NEB, INTL
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical