Perifix Catheter Connector Perifix Complete Set (Lor) Soft-Tip Perifix One Complete Set Perifix One Complete Set (Lor)Espocan W. Ds + Pencan 27gx5 3/8" (0,42xEspocan W. Ds + Pencan 27gx5 3/8" (0,42xEspocan W. Ds + Pencan 27gx5 3/8" (0,42xPerifix One Paed Set 18 Contiplex D Set,15°,18gx2 1/8", 1.3x55mm Cont S Ult 360,20°18gx100mm-Cis/Ap/Eu/SaCont. Tu. Ult 360,18gx100mm-Cis/Ap/Eu/Sa 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 B Braun Australia Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2018-RN-00928-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-07-09
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    The perifix catheter connector is a connection device used by clinicians to provide various anaesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anaesthetics. in the course of our regular post market surveillance activities we have found that the perifix catheter connector may not remain closed during use. in some cases this has led to leakage or disconnection of the catheter from the perifix catheter connector. while no serious injuries to patients, users, or third parties have been reported to date, there is a possibility of contamination of the catheter or delay of anaesthesia of different severity.
  • 조치
    Users are asked to: Review the customer letter in its entirety and ensure that all users of these products in your organization and other concerned persons are informed about this Medical Device Correction. If you are a distributor, please forward the customer letter to your customers. For continued safe use of the Perifix Catheter Connector, users are asked to review and follow the instructions described in Appendix 1 of the customer letter. Confirm receipt of the customer letter by completing the supplied confirmation slip and return it as per the instructions given.

Device

  • 모델명 / 제조번호(시리얼번호)
    Perifix Catheter ConnectorPerifix Complete Set (Lor) Soft-TipPerifix One Complete SetPerifix One Complete Set (Lor)Espocan W. Ds + Pencan 27gx5 3/8" (0,42xEspocan W. Ds + Pencan 27gx5 3/8" (0,42xEspocan W. Ds + Pencan 27gx5 3/8" (0,42xPerifix One Paed Set 18Contiplex D Set,15°,18gx2 1/8", 1.3x55mmCont S Ult 360,20°18gx100mm-Cis/Ap/Eu/SaCont. Tu. Ult 360,18gx100mm-Cis/Ap/Eu/SaMultiple Product Codes and Batch NumbersARTG Numbers: 143519, 144119 and 138970
  • Manufacturer

Manufacturer