New York Presbyterian Hospital Weill Cornell Medical Center – FDA 483, Dec 10, 2015

This FDA Form 483 document outlines observations from an inspection of a user facility, specifically a hospital. The inspection revealed two key violations related to Medical Device Reporting (MDR) requirements.

Firstly, the facility failed to submit FDA Form 3500A or its electronic equivalent to the FDA within ten working days after becoming aware of information suggesting a device may have caused or contributed to a patient's death. This was observed in early May (redacted date) when the hospital discovered that redacted patients who underwent redacted procedures using redacted devices developed redacted infections. Three of these patients subsequently expired. While these cases were reported to the FDA as one MDR event on a redacted date, the initial reporting was not within the required ten working days.

Secondly, the hospital has not developed, maintained, or implemented written MDR procedures. Specifically, their procedures do not state that a report must be submitted to the FDA within ten working days of becoming aware of information suggesting a device caused or contributed to a patient's death. Furthermore, the procedures do not specify the form required for submitting an MDR to the FDA. These deficiencies indicate a lack of a robust quality system for medical device adverse event reporting, potentially impacting patient safety and regulatory compliance.