OBJECTIVES: To assess the quality of mandatory reporting of adverse events associated with intravenous (IV) patient-controlled analgesia (PCA) devices in the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: We analyzed IV PCA device-related events, occurring in inpatient settings, reported to the MAUDE database from January 1st, 2011 through September 12th, 2016. The FDA requires all medical device manufacturers and user facilities to report any device-related adverse events that may have caused or contributed to death or serious injury within 30 calendar days and 10 calendar days to manufacturers respectively. We assessed timeliness of mandatory reporting (difference between date of report and date of event) using a 40-day and 10-day maximum reporting time criteria for manufacturers and user facilities, respectively. RESULTS: Of the 1430 IV PCA device-related events submitted to MAUDE, a total of 92 AEs including deaths (n=13) were present in structured AE data fields. Upon qualitative review of the text narratives, 7 additional cases of death absent in the structured AE field were identified. Several reports had missing information on location of event, personnel involved with event, and specific opioid involved. The average reporting time for AEs was 42 days (n: 92, S.D: 108 days, range: 0-801 days). The mean reporting time for a manufacturer-submitted event was 48 days (n: 65, SD: 116 days, range: 0-801 days); 22% of these events were submitted outside the 40-day maximum reporting time. Similarly, the mean reporting time by user facilities was 9 days (n:5, SD:2 days, range: 5-11 days). However, 3 of these events were reported outside the 10-day maximum reporting time. CONCLUSIONS: Despite regulatory requirements, our findings suggest variance in the reporting of mandatory IV PCA device-related events. Additional training and outreach programs are needed to improve the current quality of reporting of AEs associated with IV PCA devices.