Events

Alerte Ou Avis De Sécurité sur BD Neoflon™ IV cannula

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 Becton Dickinson.

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/2013/074
  • Numéro de l'événement
    CON322755
  • Date
    2013-10-10
  • Date de publication de l'événement
    2013-10-10
  • 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/CON322755?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 delay in treatment due to increased risk of the catheter buckling during initial puncture of skin. due to a change in manufacturing process, the manufacturer has become aware of an increase in reported incidents of the catheter buckling in use. becton dickinson does not currently have stock available to replace affected devices. new product is being manufactured and should be available for supply from the beginning of october. becton dickinson has not issued a field safety notice in relation to this issue.
  • Action
    Ensure staff are aware of this potential problem. Exercise additional care and vigilance when using this product and, if possible, use alternative devices until new product is available from Becton Dickinson. Report any incidents of devices buckling to the MHRA.

Device

BD Neoflon™ IV cannula
  • Modèle / numéro de série
  • Description du dispositif
    BD Neoflon™ IV cannula All lots of: Product code: 391350, size: 24 G, NHSSC code: FSP070 Product code: 391349, size: 26 G. This is a disposable device designed to gain access to peripheral veins of the patient’s blood system for rehydration, parenteral nutrition, medication delivery, blood transfusion and monitoring purposes.  This device is intended for use on neonatal, paediatric and geriatric patients.
  • Manufacturer
    Becton Dickinson

Manufacturer

Becton Dickinson