Events

Rappel de 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

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par B Braun Australia 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-2018-RN-00928-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-07-09
  • 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-2018-RN-00928-1
  • 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
    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.
  • Action
    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

Perifix Catheter Connector Perifix Complete Set (Lor) Soft-Tip Perifix One Complete Set Perifix O...
  • Modèle / numéro de série
    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
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd