Events

Premicath Neonatal PICC with Stylet Premicath with Stylet 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-00478-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-07-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00478-1
  • 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) has been revised to provide further instructions concerning the removal of the Stylet. The relevant segment is as follows: "In order to remove the stylet, disconnect between the T-Piece and catheter hub. If difficulty is experienced 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

Premicath Neonatal PICC with Stylet Premicath with Stylet
  • 모델명 / 제조번호(시리얼번호)
    Premicath Neonatal PICC with Stylet Premicath with Stylet Product Code: VY-1261.153 Premicath 1FR 20cm Split NeedleProduct Code: Vy-1261.203 Premicath with Stylette Product Code: VY-1261.205 Premicath W Pink Hub Secure Device Product Code: VY-1261.207 Premicath 1FR 28g 30cm w/stylet Product Code: VY-1261.306 ARTG Number: 141227(Device Technologies Australia Pty Ltd - Catheter, intravascular, general-purpose)
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd