Set, Administration, Intravascular

What the Data Shows About Set, Administration, Intravascular

The FDA MAUDE database aggregates 207,687 adverse-event reports for Set, Administration, Intravascular spanning the period from 1992 through 2026. Of these, 438 are classified event_type Death, 21,566 as event_type Injury, and 184,170 as event_type Malfunction. Event_type is one code per report and is not the same population as the Patient Outcomes chart (FDA patient-outcome codes; see methodology). Report counts do not by themselves indicate a device is unsafe, widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 6 distinct event types and, separately, 16 patient-outcome categories (outcome percentages use the outcome-row total, not the event_type total). A total of 20 distinct product-problem codes appear in the reports, with Fluid/Blood Leak topping the list at 27,956 reports. Reports are associated with 9 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 35 years of MAUDE data, with the peak single-year volume reaching 47,209 reports - trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 20 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on 2026-05-15. This page is informational and is not medical advice, discuss device-safety questions with your healthcare provider.