Events

Rappel de Flexi-Slip endotracheal tube stylets(Intended for use in facilitating intubation of tracheal tubes.)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Teleflex Medical 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-2015-RN-00874-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-09-08
  • 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-00874-1
  • 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
    There have been reports of the plastic coating of the stylet splitting and/or breaking off of the stylet. this may result in a piece of plastic totally or partially occluding the patient’s airway and impairing ventilation, or necessitating invasive removal procedures in order to prevent complications such as atelectasis or pneumonia. over 200,000 units have been distributed and there have been 4 complaints to august 2015. this gives rise to a complaint rate of 0.00205%.No patient injuries have been reported related to this issue.
  • Action
    Customers are asked to inspect their stock, quarantine any affected units from use and to follow the instructions on the acknowledgement form in order to have those units collected. An appropriate account credit will then be issued. This action has been closed-out on 22/08/2016.

Device

Flexi-Slip endotracheal tube stylets(Intended for use in facilitating intubation of tracheal tubes.)
  • Modèle / numéro de série
    Flexi-Slip endotracheal tube stylets(Intended for use in facilitating intubation of tracheal tubes.)SAP/Catalogue Number: 502501-000060Batch Numbers: 14BG27, 14FG03ARTG Number: 214058
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd