Events

Alerte Ou Avis De Sécurité sur Nasogastric feeding tubes – Ryles tubes (weighted tip)

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 Vygon Ltd.

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/2013/009
  • Numéro de l'événement
    CON239462
  • Date
    2013-02-26
  • Date de publication de l'événement
    2013-02-26
  • 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/CON239462?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 incorrect placement of the feeding tube due to incorrectly applied depth markings. despite issuing two field safety notices in january 2013, vygon ltd has not received sufficient confirmation from users that they have received and acted on this information.
  • Action
    Identify and quarantine any affected devices. Ensure all users are aware of the manufacturer’s Field Safety Notices (dated 3 January 2013 and 21 January 2013). Return the confirmation requests in the FSNs to the manufacturer. If patients have affected tubes in situ, confirm correct placement before further use, following local protocols.

Device

Nasogastric feeding tubes – Ryles tubes (weighted tip)
  • Modèle / numéro de série
  • Description du dispositif
    Nasogastric feeding tubes – Ryles tubes (weighted tip). Size 12FG 125cm, product code: 392.12, lot number: 160412FG. Size 14FG 125cm, product code: 392.14, lot number: 100512FF. The affected product codes on the manufacturer’s website and device labels are specified as ‘392.12’ and ‘392.14‘.  The same products are referred to as ‘0392.12’ and ‘0392.14’ respectively in the manufacturer’s Field Safety Notices.
  • Manufacturer
    Vygon Ltd

Manufacturer

Vygon Ltd