Events

Alerte Ou Avis De Sécurité sur Reinforced endotracheal (ET) tubes – Murphy; Magill; Murphy with stylet; Magill with stylet

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Unomedical (a ConvaTec company).

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2013/029
  • Numéro de l'événement
    CON272226
  • Date de publication de l'événement
    2013-05-08
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON272226?tabName=allTabs
  • Notes / Alertes
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notes supplémentaires dans les données
  • Cause
    Potential for inadequate patient ventilation. the affected tubes may delaminate, which can lead to constriction of the lumen, resulting in a reduction of airflow to the patient. the manufacturer issued a field safety notice, dated 13 march 2013, to withdraw the affected devices but has not had confirmation from a significant number of users that they have received and acted upon this information. this alert has been issued in support of the manufacturer’s actions. delamination is the detachment of the plastic inner layers of the endotracheal tube from one another because of poor adhesion. the problem has now been rectified.
  • Action
    Identify, quarantine and do not use affected devices. Seek alternative devices immediately. Return affected devices and the recall questionnaire to the manufacturer.

Device

Reinforced endotracheal (ET) tubes – Murphy; Magill; Murphy with stylet; Magill with stylet
  • Modèle / numéro de série
  • Description du dispositif
    Reinforced endotracheal (ET) tubes – Murphy; Magill; Murphy with stylet; Magill with stylet. Available under three brand names: Unomedical UnoFlex TM EuromedicalTM TrachealFlex TM PharmaPlast Specific sizes and lots are affected. Reinforced endotracheal tubes are single-use medical devices comprised of an armoured, hollow cylinder inserted orally or nasally into the trachea. Pages four to six of the Field Safety Notice (FSN) provide guidance on how to identify the devices. The reference numbers and lot numbers of all the affected devices are listed on pages 10 to 38 of the FSN.
  • Manufacturer
    Unomedical (a ConvaTec company)

Manufacturer

Unomedical (a ConvaTec company)