Events

Field Safety Notices about Betafine Universal Pen Needles 30G-8mm

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Promisemed Hangzhou Meditech Co. 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
    Field Safety Notice
  • Date
    2016-09-29
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    We have received occasional complaints of betafine universal pen needles 30g-8mm with lot number 513061 and have therefore decided to proactively take action and recall this product. sporadically, the steel cannula becomes stuck in the rubber seal of the pen’s insulin cartridge after insulin injection. in such instances, there exists a slight danger of pricking oneself with the already used cannula. the cause has already been established and resolved and therefore we can assure you that only pen needles from lot number513061 can be affected by this issue.

Device

Betafine Universal Pen Needles 30G-8mm

Manufacturer

Promisemed Hangzhou Meditech Co. Ltd