Events

Alerte Ou Avis De Sécurité sur Portex® endotracheal tube holder (2.5mm and 3.0mm) sold as stand-alone products or packaged in intubation kits

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 Smiths Medical.

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/2014/036
  • Numéro de l'événement
    CON456001
  • Date
    2014-09-17
  • Date de publication de l'événement
    2014-09-17
  • 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/CON456001?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
    Risk of extubation or delay to therapy as there may be difficulty passing a suction catheter through the endotracheal tube when the holder is locked. there may also be difficulty locking the holder. this is due to a manufacturing problem, which means the holder might compress the endotracheal tube. smiths medical has issued a field safety notice (fsn) recalling affected devices but hasn’t had sufficient confirmation that customers have received it and acted on it.
  • Action
    Identify affected devices as described in the FSN and quarantine them. Complete and return the confirmation form in the FSN. Arrange for replacement devices with Smiths Medical.

Device

Portex® endotracheal tube holder (2.5mm and 3.0mm) sold as stand-alone products or packaged in in...
  • Modèle / numéro de série
  • Description du dispositif
    Portex® endotracheal tube holder (2.5mm and 3.0mm) sold as stand-alone products or packaged in intubation kits. Specific product codes and lot numbers. If relevant to you, the national supply codes are as follows: Scotland SKU: Smiths code NDC code H4001PS 054220 H4001S 007424 H4002PS 014408 H4002S 039364 H4051 - H4052 - England NPC: use manufacturer’s codes in the FSN Northern Ireland: use manufacturer’s codes in the FSN Wales NSV: use manufacturer’s codes in the FSN
  • Manufacturer
    Smiths Medical

Manufacturer

Smiths Medical