Events

Alerte De Sécurité sur T-Piece Circuit

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

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
    2015-10-06
  • Date de publication de l'événement
    2015-10-06
  • 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_20151006a.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: mercury medical t-piece circuit the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning t-piece circuit, manufactured by mercury medical. product affected was shipped after 18 january 2012. the affected part numbers and the corresponding lot numbers are: t-piece neonatal circuit kit, disposable part number: m1091316vs; lot number: 14049 and greater part number: m1091335vs; lot number: 14043 and greater part number: m1091365vs; lot number: 14051 and greater neo-tee resuscitator part number: 10-50805; lot number: 1426550805 and greater part number: 10-50809; lot number: 1227550811 and greater part number: 10-50811; lot number: 1227850809 and greater t-piece resuscitator circuit part number: 10-50900; lot number: 1402050900 and greater part number: 10-50901; lot number: 1427650901 and greater part number: 10-50902; lot number: 1324850902 and greater the t-piece circuit is a component used in conjunction with various t-piece resuscitation devices. according to the safety alert, there is a potential that a silicone mask with a 15 mm male port is being able to be forcibly inserted into the protective cap covering the opening of the t-piece circuit. incorrect use of the product in this way will result in complete occlusion of the patient circuit and consequent failure to ventilate the patient. the manufacturer advises affected users to immediately notify all personnel subject to using these devices to remove the protective cap before connecting a mask. besides, the manufacturer is in process to physically eliminate the potential for this erroneous use. the instructions for use are also being updated to warn users to remove the cap before use. for details, please refer to the mhra website:https://www.Gov.Uk/government/publications/safety-information-from-manufacturers-field-safety-notices/field-safety-notices-28-september-to-2-october-2015 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 6 october 2015.

Device

T-Piece Circuit
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Mercury Medical T-Piece Circuit
  • Manufacturer
    Mercury Medical

Manufacturer

Mercury Medical