Alerte Ou Avis De Sécurité sur Neonatal endotracheal tube SCP clamp/holder

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 Capatex 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/2012/029
  • Numéro de l'événement
    CON152757
  • Date
    2012-05-24
  • Date de publication de l'événement
    2012-05-24
  • Pays de l'événement
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
  • 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 airway loss due to slippage or airway obstruction, as a result of over-tightening of the clamp/holder. capatex is recalling affected products and has advised users of the issue in field safety notices (see appendix). this medical device alert is being issued to reinforce the manufacturer’s actions. a change was made to the composition of the plastic material used, to make the clamps/holder dehp-free. this affected the physical properties of the clamps, resulting in an increased risk of slippage. to counteract this, capatex added an extra notch on the clamp. however, this introduced the possibility of over-tightening and occlusion of the internal diameter of the endotracheal tube. all clamps from lot number 1002854 onwards have been manufactured using a new material.
  • Action
    Identify affected devices and quarantine them. Contact Capatex to arrange for devices to be exchanged or to confirm that you have none in stock. Follow the advice in the FSN dated February 2012 (see appendix). In particular, follow advice on Capatex clamp/holder size and corresponding size of endotracheal tube to be used.

Device

  • Modèle / numéro de série
  • Description du dispositif
    Neonatal endotracheal tube SCP clamp/holder. Product codes: CM – SCP020 – ENDO CM – SCP025 – ENDO CM – SCP030 – ENDO CM – SCP035 – ENDO CM – SCP040 – ENDO Lot numbers up to and including 1002853
  • Manufacturer

Manufacturer