Events

Suction catheters, gastro-enteral tubes, intermittent urology catheters and sterile urine drainage bags 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 ConvaTec Limited 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
  • 날짜
    2018-11-14
  • 사례 출판 날짜
    2018-11-14
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/suction-catheters-gastro-enteral-tubes-intermittent-urology-catheters-and-sterile-urine-drainage-bags-potential-breach-in-sterile-barrier-packaging-mda-2018-034
  • 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
    Manufactured by convatec limited – use of affected devices may increase risk of patients getting infections.
  • 조치
    Refer to the manufacturer’s Field Safety Notice FSN for a list of affected product codes and affected lots. Stop using and quarantine affected devices as directed in the manufacturer’s FSN. Complete the ‘Recall Response Form for END USERS’ in the FSN and return to convatecproductrecall@stericycle.com to arrange return of affected device(s). Report any incidents or complaints involving this product to unomedical-uk.customerservice@convatec.com.

Device

Suction catheters, gastro-enteral tubes, intermittent urology catheters and sterile urine drainag...
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Affected devices can only be identified by comparing product code and manufacture date stated on the packaging to the product list in the manufacturer’s FSN. The breach in the packaging is not visible.In addition to the FSN, which details the affected products, please refer to the spreadsheet which accompanies this MDA for additional unique device identification information and national supply chain codes (where available).
  • Manufacturer
    ConvaTec Limited

Manufacturer

ConvaTec Limited
  • 제조사 주소
    ConvaTec Limited Tel: 01244 832206 Email: convatecproductrecall@stericycle.com, unomedical-uk.customerservice@convatec.com.
  • 제조사 모회사 (2017)
    Triona Holding Sa
  • Source
    MHRA