Following our examination of the returned sample and investigations conducted together with our contract manufacturer (including a review of batch records and retention samples), we are unable to determine any manufacturing issue that may have caused the reported event.The silicone material used for the valves is unchanged, and there had been no changes to the design of the valve at the time of the production of this batch.Mdi has no other recorded reports of this type of event occurring in any other market.In the absence of any manufacturing issues being identified, it is most likely in our view that tearing has been caused during the cleaning of the space chamber.It is possible to damage the valve if the base is removed and the space chamber is cleaned with something like a bottle brush.Pushing though the valve with enough force may initiate tearing of the valve at the cross cut (even using a relatively blunt implement) and this tear may then be propagated through the valve, along any creases/edges in the valve.This does require a reasonable amount of force, and the use of a bottle brush or similar item is not contained in the cleaning instructions provided with the device.The space chamber should only be cleaned according to the process outlined in the instructions for use.
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