Safety Alert Or Field Safety Notices for Bag valve mask (BVM) manual resuscitation system

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 Intersurgical.

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 Number
    MDA/2018/009
  • Date
    2018-03-02
  • Event Date Posted
    2018-03-02
  • Event Country
  • Event Source
    MHRA
  • Event Source URL
  • 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
    Please see images in the document below which show the incorrect and correct orientation of the directional valves. The green nipples on the valves should not point in the same direction.
    Bag valve mask (BVM) manual resuscitation system MDA/2018/009
  • Reason
    Manufactured by intersurgical – valves may be incorrectly oriented, resulting in overpressure of the bag (mda/2018/009).
  • Action
    Identify and immediately quarantine affected devices (see Field Safety Notice (FSN) for model and lot numbers). Replace with an alternative device where available. If no alternative is available, check the orientation is correct for all valves on quarantined devices before releasing them from quarantine (see Problem). This can be done without opening the packaging. Do not use if the orientation of the valve is incorrect. Follow the instructions in the manufacturer’s FSN to return affected devices. Return the response form to Intersurgical, even if you don’t have affected devices left in stock.

Device

  • Model / Serial
  • Product Description
    Specific lot numbers from the following models are affected. See FSN for lot numbers.Intersurgical Code UDI No. NHSSC Code (England only) 7150000 5030267073238 FDE656 7151000 5030267073245 N/A 7152000 5030267073252 FDE658 7152005 5030267102259 N/A 7152006 5030267105632 N/A 7152007 5030267104901 N/A 7152012 5030267143061 N/A 7153000 5030267073276 FDD4288 7153008 5030267124473 N/A 7154000 5030267073283 FDE660
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Intersurgical Tel: 0118 9656 362priority@intersurgical.co.uk
  • Manufacturer Parent Company (2017)
  • Source
    MHRA