Devices › Device types
FDA product code FPA · class 2 · General Hospital
Set, administration, intravascular: medical device reports filed with FDA
349,387 reports carry this product code, 1992–2026; 30 brands with a page.
- 349,387
- reports with this product code
- 1.3% of all MAUDE reports
- 155,319
- reports, 12 months to August 2026
- 42,263 in the 12 months before
- 79.3%
- classified as malfunction
- 62.3% across all reports
- 0.2%
- classified as death, as reported
- 0.9% across all reports
Product code FPA is FDA's classification for "Set, administration, intravascular" (general Hospital panel), a class 2 device. 349,387 medical device reports carry this product code, 1.3% of the MAUDE database, from January 1992 to August 2026.
155,319 reports arrived in the 12 months to August 2026, up 268% from 42,263 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (79.3%), injury (20%) and other (0.3%). 30 brand names with a page on this site carry this code; the brands table is ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Brands with this product code
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| Unomedical Devices De C V | 90,085 | 25.8% |
| Unomedical A/S | 87,269 | 25% |
| Carefusion | 18,347 | 5.3% |
| Sistemas Medicos Alaris De C V | 15,752 | 4.5% |
| Baxter Healthcare | 14,487 | 4.1% |
| Unomedical Um-D | 11,117 | 3.2% |
| Smiths Medical Asd | 8,228 | 2.4% |
| St Paul | 7,799 | 2.2% |
| Roche Diabetes Care | 5,721 | 1.6% |
| B Braun Medical | 5,006 | 1.4% |
| Baxter Healthcare - Aibonito | 4,562 | 1.3% |
| Icu Medical De Mexico S De R L De C V | 3,550 | 1% |
| C R Bard Basd -3006260740 | 3,452 | 1% |
| Icu Medical Costa Rica | 2,912 | 0.8% |
| Disetronic Medical Systems | 2,772 | 0.8% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type and report source
Event type
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Loss of or failure to bond | 48,928 | 14% |
| Fluid/blood leak | 47,140 | 13.5% |
| Premature separation | 46,804 | 13.4% |
| Material twisted/bent | 42,481 | 12.2% |
| Leak/splashthe device leaked | 39,241 | 11.2% |
| Complete blockage | 14,768 | 4.2% |
| Detachment of device or device componentpart of the device came off | 13,719 | 3.9% |
| Use of incorrect control/treatment settings | 11,747 | 3.4% |
| Infusion or flow problema problem with flow or infusion | 10,601 | 3% |
| Breakthe device broke | 7,493 | 2.1% |
| Material separation | 6,463 | 1.8% |
| Disconnection | 6,326 | 1.8% |
| Partial blockage | 5,710 | 1.6% |
| Crackthe device cracked | 5,396 | 1.5% |
| Device alarm system | 5,191 | 1.5% |
| Device handling problem | 4,722 | 1.4% |
| No flow | 3,597 | 1% |
| Air/gas in device | 3,119 | 0.9% |
| Device displays incorrect message | 2,959 | 0.8% |
| Material deformation | 2,803 | 0.8% |
Questions about set, administration, intravascular reports
What is product code FPA?
FDA's classification code for "Set, administration, intravascular", class 2, reviewed by the general Hospital panel. Every device report carries the product code of the device involved.
How many reports carry this code?
349,387 reports through August 2026, 155,319 of them in the latest 12 months.
Which brands appear most often?
Inset Guard (47,253), Inset (26,402), Quick Set (23,329), Autosoft Xc (20,269) and Autosoft 90 (12,142). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." Brands differ in how many are in use, how long they have been sold and how reports are collected.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.