Events

Alerte De Sécurité sur Kimvent Subglottic Suctioning Endotracheal Tubes

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

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
    2014-11-21
  • Date de publication de l'événement
    2014-11-24
  • 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_20141124.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: halyard health (kimberly-clark) kimvent* subglottic suctioning endotracheal tubes medical device manufacturer, halyard health, inc. (formerly known as kimberly-clark health care) has issued a field safety notice concerning its kimvent* microcuff* subglottic suctioning endotracheal tube, 8.0mm. the affected product code is 13222. the affected lot numbers, shipped from 20 december 2013 to 30 october 2014, are aa3213, aa3213v03, aa3227, aa3227v01, aa3239, aa3239v01, aa3245, aa3245v02, aa3249, aa3249v01, aa3249v03, aa3253v02, aa3269v01, aa3274, aa3274v01, aa3274v04, aa4038, aa4038v03, aa4038v04, aa4038v06, aa4062, aa4062v01, aa4062v03, aa4062v04, aa4083, aa4083v02, aa4097, aa4097v02, aa4097v04, aa4104v01, aa4104v02, aa4111, aa4111v01, aa4111v02, aa4113v01, aa4125v03, aa4134v01, aa4146v01, aa4146v04, aa4155v03, aa4167v01, aa4170v01, aa4174v01, aa4217v01 and aa4226v01. according to the manufacturer, the standard kimvent* microcuff* endotracheal tubes are not impacted. the manufacturer has identified that the inflation line of certain kimvent* microcuff* subglottic suctioning endotracheal tubes may detach from the endotracheal tube during use. in most reported cases, detachment of the inflation line was identified immediately, while in other cases, eventual decrease in ventilator circuit pressure triggered ventilator alarms. in the majority of occurrences, re-intubation of the patient was required to re-establish the desired pressure in the ventilator circuit. one suspected case of ventilator associated pneumonia was reported after inflation line detachment, which resolved with standard antibiotic treatment. the manufacturer has initiated a voluntary product recall on the affected lots of devices. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 24 november 2014.

Device

Kimvent Subglottic Suctioning Endotracheal Tubes
  • Modèle / numéro de série
  • Classification du dispositif
    Anesthesiology Devices
  • Description du dispositif
    Medical Device Safety Alert: Halyard Health (Kimberly-Clark) Kimvent* Subglottic Suctioning Endotracheal Tubes
  • Manufacturer
    Halyard Health

Manufacturer

Halyard Health