Events

Alerte Ou Avis De Sécurité sur Central Venous Catheters: Multicath Expert 5 Lumen (9.5FG/16cm)

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.

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/2014/045
  • Numéro de l'événement
    CON482907
  • Date
    2014-12-05
  • Date de publication de l'événement
    2014-12-05
  • 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/CON482907?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 catheter and delay to treatment. this is due to a manufacturing problem resulting in: decreased length of the catheter. the catheter tip may not reach the desired position during placement. catheters with four lumens (instead of five). this may then require additional catheter or extension sets after placement. vygon has issued a field safety notice (fsn), dated 16 september 2014, to its customers recalling affected catheters but has not received enough replies to assure themselves that users have received and acted on this information.
  • Action
    Identify and quarantine affected catheters. Complete the confirmation form in the FSN to arrange for replacement catheters if necessary. Return the form to the manufacturer. All those responsible for the purchase and use of this device.

Device

Central Venous Catheters: Multicath Expert 5 Lumen (9.5FG/16cm)
  • Modèle / numéro de série
  • Description du dispositif
    Central Venous Catheters: Multicath Expert 5 Lumen (9.5FG/16cm). Product Code: 8159.167 Lot/Batch number: 020414GE If relevant to you, the national supply codes are as follows: England NPC: FSU144 . Northern Ireland: Device supplied by PaLS as a 'Non Stock Item' Scotland SKU: NP106/12 Wales NSV: FSX0677
  • Manufacturer
    Vygon

Manufacturer

Vygon