Events

Certofix Duo Certofix Trio Drucafix 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 B. Braun Melsungen AG 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
  • 날짜
    2016-12-21
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • 데이터 추가 비고
  • 원인
    During production we observed in an isolated case that a female luer connector was not fully connected to the extension line of the certofix catheter. upon further intensive testing, we could identify the root cause of the defect and are able to limit a possible occurrence of the failure to the below listed product/batch combinations. the failure appears only at white and yellow luer connectors and occurs at a very low rate. the failure can be identified by the user. a disconnection of the luer connector from the extension line has the potential to cause air embolism and other serious patient harm. we therefore advise to discontinue usage of the affected product/batch combinations or - in case of an undersupply situation - identify potentially affected products according to the below described procedure. .

Device

Certofix Duo Certofix Trio Drucafix
  • 모델명 / 제조번호(시리얼번호)
    Article Number Article Name Batch 4161211 CERTOFIX DUO V 720 16M15A8551 4161319 CERTOFIX DUO V 730 16M21A8551 4163214 CERTOFIX TRIO V720 16M17A8551 16M16A8551 4163306 CERTOFIX TRIO S 730 16M18A8551 4164158 CERTOFIX DUO S 715 16M24A8551 4167385 CERTOFIX DUO S 720 16M18A8551 4167408 CERTOFIX TRIO S 720 16M28A8551 4162200E CERTOFIX DUO 720 16M21A8551 16M22A8551 4163206E CERTOFIX TRIO 720 16M11A8551 4167408S CERTOFIX SAFETY TRIO S 720 16M08A8551 4166906 CERTOFIX DUO PAED S 408 16M24A8551 4166922 CERTOFIX DUO PAED S 413 16M18A8551 227599 DRUCAFIX WITH SPLITTOCAN 16L20A8701 16L07A8701 4162153 CERTOFIX TRIO V 715 16M22A8551 16M24A8551 16M25A8551
  • Manufacturer
    B. Braun Melsungen AG

Manufacturer

B. Braun Melsungen AG