Events

Alerte De Sécurité sur Short Term Acute Dialysis Catheters

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Joline.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2013-06-17
  • Date de publication de l'événement
    2013-06-17
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130617a.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: joline short term acute dialysis catheters the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning short term acute dialysis catheters, manufactured by joline. the affected products were manufactured from jun 2012 to feb 2013. in the course of continuous market surveillance, the manufacturer became aware that occasionally there could be an increased risk of hairline cracks at the connectors of these catheters. it was observed that during the application of the catheter crack formation sporadically occurred. although there has been no patient endangering so far, blood loss cannot be excluded. by means of optimized manufacturing processes and improvements of the design, the mechanical and chemical resistance could be enhanced. until these measures are completely implemented, the manufacturer asks customers to waive alcoholic disinfectants, in no case connect before complete drying as already indicated in the instructions for use and avoid excessive forces when connecting as well as ensure a regular and frequent control of the connectors, and securely clamp affected catheters with the mounted safety clamp and change the catheter. furthermore, the manufacturer advises distributors to stop selling the affected products. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con286760 if you are in possession of the product, please contact your supplier for necessary actions. posted on 17 june 2013.

Device

Short Term Acute Dialysis Catheters
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Joline Short Term Acute Dialysis Catheters
  • Manufacturer
    Joline

Manufacturer

Joline