Events

Nutriline and Nutriline Twinflo Peripherally inserted central catheters (PICC)NUTRILINE W STYLET AND MICROFLASH 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Device Technologies 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-00842-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-07-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00842-1
  • 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
    Device technologies australia (dta) has been made aware by the manufacturer, vygon gmbh & co kg, of reported incidents where the stylet snapped upon removal when the user made a second attempt to remove the stylet from the catheter.
  • 조치
    DTA is advising that the Instructions for Use (IFU) have been revised to provide further instructions concerning the removal of the Stylet. The relevant segment is as follows: "If difficulty is experienced removing the stylet stop, let vein rest for a minute and try removal again very slowly. Gentle flushing of the catheter with diluted lipid solution (preferred) or saline assists in stylet removal. If resistance still remains, withdraw catheter and stylet simultaneously".

Device

Nutriline and Nutriline Twinflo Peripherally inserted central catheters (PICC)NUTRILINE W STYLET ...
  • 모델명 / 제조번호(시리얼번호)
    Nutriline and Nutriline Twinflo Peripherally inserted central catheters (PICC)NUTRILINE W STYLET AND MICROFLASH Product Code: VY-1252.030 NUTRILINE TWINFLO WITH STYLET Product Code: VY-1252.230 ARTG Number: 141227(Device Technologies Australia Pty Ltd - Catheter, intravascular, general-purpose)
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd