Events

Alerte De Sécurité sur FemoSeal Vascular Closure Systems

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

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
    2017-08-22
  • Date de publication de l'événement
    2017-08-22
  • 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_20170822a.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: terumo femoseal vascular closure systems medical device manufacturer, terumo medical corporation, has issued a safety alert concerning its femoseal vascular closure systems [product reference code: c11202]. the manufacturer is initiating a voluntary recall of select production lots of femoseal vascular closure systems in response to an increase in device related malfunction complaints. specifically, after the deployment of the inner locking disc, complaints allege that the button will not spring back as intended, preventing the outer locking disc from deploying and completing the procedure. when this failure occurs, options for the clinician include manual compression or surgical cut down. upon further review, devices associated with this complaint mode (approximately 1/600 per current complaint date) reflect the internal entrapment of the device’s suture assembly. suture entrapment prevents the proper actuation of the device to complete the surgical procedure. internal controls have been established in manufacturing to eliminate the potential for this defect. product replacement is on-going. according to the local supplier, the affected products are distributed in hong kong if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 august 2017.

Device

FemoSeal Vascular Closure Systems
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Terumo FemoSeal Vascular Closure Systems
  • Manufacturer
    Terumo Medical Corporation

Manufacturer

Terumo Medical Corporation