Events

Safety Alert Or Field Safety Notices for Gastrostomy devices: Measuring device, Direct dilation kit, Balloon gastrostomy kit

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Medicina Ltd.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2014/032
  • Event Number
    CON448005
  • Date
    2014-08-20
  • Event Date Posted
    2014-08-20
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON448005?tabName=allTabs
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    Risk of infection as the balloon gastrostomy kit may contain out-of-date devices.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

Gastrostomy devices: Measuring device, Direct dilation kit, Balloon gastrostomy kit
  • Model / Serial
  • Product Description
    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
    Medicina Ltd

Manufacturer

Medicina Ltd
  • Manufacturer Parent Company (2017)
    Luan Srl
  • Source
    MHRA