Events

Rappel de MiniCap with Povidone-Iodine Solution

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Baxter Healthcare Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00058-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-01-22
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00058-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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).
  • Action
    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