FDA 483 - Brigham and Women's Hospital - December 10, 2015

This FDA Form 483 documents observations from an inspection of Brigham and Women's Hospital. The facility failed to submit FDA Form 3500A or its electronic equivalent within ten working days after becoming aware of information suggesting a device caused or contributed to a patient's death. Specifically, a patient death associated with a redacted model, serial number redacted, procedure was not reported to the FDA.

Additionally, the facility did not submit FDA Form 3500A or equivalent to the known device manufacturer within ten working days for serious injuries. A review of 48 Medical Device Reports (MDRs) submitted via MedSun from January 1, 2014, to December 9, 2015, revealed four MDRs submitted more than ten working days after the event date.

Written MDR procedures have not been adequately developed, maintained, and implemented. Policy Number: 5.4.7, dated 8/15, titled "External Regulatory Reporting of Adverse Events," contains only two sentences regarding FDA reporting, which the Director of Risk Management stated are the hospital's sole written procedure for MDR reporting.

Finally, MDR event files have not been established and maintained. The Director of Risk Management stated the hospital does not maintain files other than what is reported through MedSun. Records of deliberations and decision-making processes used to determine reportability for deaths or serious injuries were unavailable for inspection.