Medical Device Material Degradation

Issue associated with an undesired separation and/or a visible opening along the length or width in the materials that are used in…

Issue associated with the written, printed or graphic material that is affixed to a medical device or any of its containers or…

Issue associated with the servicing of a device.

Issue associated with the non-compliance or non-performance to manufacturer specifications relating to device routine maintenance, i.e., periodic inspection, failure detection, repair, and…

Issue associated with the device being in a nonfunctional or inoperable state and cannot be used unless the causes of the inoperability…

Issue associated with the device not being compatible with another device component or substance (medication, body fluid etc) that it contains or…