Events

MiniCap with Povidone-Iodine Solution 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Baxter Healthcare 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-2015-RN-00058-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-01-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00058-1
  • 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
    Baxter received complaints indicating that the iodine sponge of the minicap was fully separated from the cap, partially protruding from the cap, or missing.This may give rise to infusion of micro-organisms or by-products of microbes or other foreign materials into the peritoneal cavity, which may lead to bacterial or fungal peritonitis and/or infusion of inert foreign material into the peritoneal cavity which may lead to tissue injury or peritoneal membrane injury.These events are considered as catastrophic, however, the likelihood of this occuring has been calculated by the manufacturer as improbable (less than one in one million chance).
  • 조치
    Users are advised to inspect the product to ensure there is no damage to the MiniCap and that the sponge is fully within the cap. Do not use the product if the sponge is protruding or missing from the cap, and obtain a new MiniCap. For further information please see https://www.tga.gov.au/alert/minicaps-povidone-iodine-solution-used-peritoneal-dialysis.

Device

MiniCap with Povidone-Iodine Solution

Manufacturer

Baxter Healthcare Pty Ltd