Caused or contributed

The threshold is low: it is enough that the device may have been a factor, including through user error or labeling. Deciding that an event was not caused or contributed to by the device needs documented reasoning, not just a lack of proof.

Caused or contributed means that a death or serious injury was or may have been attributed to a medical device, or that a medical device was or may have been a factor in a death or serious injury, including events occurring as a result of: (1) Failure, (2) Malfunction, (3) Improper or inadequate design, (4) Manufacture, (5) Labeling, or (6) User error.

21 CFR, 803.3