Events

Alerte Ou Avis De Sécurité sur Steel cannula infusion sets

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 Unomedical a/s.

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
  • Numéro de l'événement
    MDA/2015/027
  • Date
    2015-07-23
  • Date de publication de l'événement
    2015-07-23
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://www.gov.uk//drug-device-alerts/steel-cannula-infusion-sets-risk-of-needle-breaking-in-use
  • 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
    Unomedical a/s issued an FSN in May 2015 to distributors but does not know where all the sets were sent.
  • Cause
    (unomedical a/s) may cause leakage of medication and require surgical intervention to remove the needle (mda/2015/027).
  • Action
    Ensure all users are aware of the potential for the set’s needle to break (see field safety notice (FSN) for details of affected sets). Ensure procedures are in place for all users, including patients, to: check the infusion sets prior to use and do not use sets with bent or damaged needles remove sets carefully and check that they are intact after use receive and understand the instructions for use contact a health care provider for clinical assessment if a needle has broken

Device

Steel cannula infusion sets
  • Modèle / numéro de série
  • Description du dispositif
    The following steel cannula infusion sets are affected:SURE-T SURE-T Paradigm contact detach contact Sub Q neria neria detach neria multi thalasetFurther device details including lot numbers and item numbers are in the manufacturer’s FSN.
  • Manufacturer
    Unomedical a/s

Manufacturer

Unomedical a/s
  • Adresse du fabricant
    Cindie Vandfeldt Telephone: +45 4642 7880Email: FSCA-ID@convatec.com
  • Société-mère du fabricant (2017)
    Triona Holding Sa
  • Source
    MHRA