North Carolina Devicemaker Written Up for Unfiled MDR Reports

October 22, 2019

The FDA cited a North Carolina medical equipment manufacturer over failure to file MDR reports with the agency over leaking products.

An agency inspection of the Custom Assemblies facility revealed that the company neglected to submit MDR reports for leaking anesthesia administration sets involved in approximately 34 complaints between 2017 and 2018.

The FDA said that the issues with the device “would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.”

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