Alerte Ou Avis De Sécurité sur Gastrostomy devices: Measuring device, Direct dilation kit, Balloon gastrostomy kit

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 Medicina 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/2014/032
  • Numéro de l'événement
    CON448005
  • Date
    2014-08-20
  • Date de publication de l'événement
    2014-08-20
  • 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    Risk of infection as the balloon gastrostomy kit may contain out-of-date devices. the sterility of these devices cannot be assured. in addition, the safety and performance of these devices has not been properly evaluated and so the ce marking of all of these devices is invalid. medicina issued three field safety notices (fsns) in june 2014 but has not had sufficient confirmation that customers have received and acted on these notices.
  • Action
    Do not use affected devices. Quarantine and return them to the manufacturer as described in the FSNs: Measuring device FSN Direct dilation kit FSN Balloon gastrostomy kit FSN For patients with gastrostomy catheters the MHRA currently considers that the benefits of continuing to use the device outweigh the risks of removal and replacement. Return the email / fax back form in the FSNs to the manufacturer. Personnel involved in the purchase, supply and distribution of these devices.

Device

  • Modèle / numéro de série
  • Description du dispositif
    Gastrostomy devices: Measuring device – product code: BM01 Direct dilation kit – product codes: DD12fr, DD14fr and DD16fr Balloon gastrostomy kit – product codes: EK12fr, EK14fr, EK16fr, EK18fr, EK20fr, EK22fr and EK24fr All batches. If relevant to you, the NHS Supply Chain Codes are as follows: Medicina Ltd product code NPC Product description DD12fr FWM1726 Gastrostomy Kit Direct dilation gastrostomy kit 12FR DD14fr FWM1727 Gastrostomy Kit Direct dilation gastrostomy kit 14FR DD16fr FWM1728 Gastrostomy Kit Direct dilation gastrostomy kit 16FR EK12fr FWM1729 Gastrostomy Kit Universal balloon gastrostomy kit with clamp 12FR EK14fr FWM1730 Gastrostomy Kit Universal balloon gastrostomy kit with clamp 14FR EK16fr FWM1731 Gastrostomy Kit Universal balloon gastrostomy kit with clamp 16FR EK18fr FWM1732 Gastrostomy Kit Universal balloon gastrostomy kit with clamp 18FR EK20fr FWM1733 Gastrostomy Kit Universal balloon gastrostomy kit with clamp 20FR EK22fr FWM1734 Gastrostomy Kit Universal balloon gastrostomy kit with clamp 22FR EK24fr FWM1735 Gastrostomy Kit Universal balloon gastrostomy kit with clamp 24FR
  • Manufacturer

Manufacturer

  • Société-mère du fabricant (2017)
  • Source
    MHRA