Medical Device Contamination during Use

Issue associated with the undesired introduction of impurities either chemical or microbiological in nature, or of foreign matter into or onto the device at the user facility. (Food and Drug Administration)

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Medical Device Contaminated during Manufacturing or Shipping

Issue associated with the presence of any unexpected foreign substance found on the surface or in the package materials, which may affect…

Medical Device Component Or Accessory Terminology FDA CDRH

Terminology used for medical components and accessories in safety reports and FDA CDRH documents during both pre and post approval periods of…

Medical Device Component or Accessory Incompatibility

Issue associated with the incompatibility of any device and/or device components while being operated in the same use environment thereby leading to…

Medical Device Component or Accessory

A physical object that is a medical device or a component or accessory of a medical device.

Medical Device Component Missing

Issue associated with the absence of any part, substance, software, hardware, or raw material that is designed to be put together as…

Medical Device Component Defective

Issue associated with a device component having flaws of dimensional deviations greater than acceptable for the intended use.