Devices › Set, administration, intravascular
Device brand name · Set administration intravascular
Comfort: medical device reports filed with FDA
2,169 reports name it, 2025–2026. Manufacturer given most often on reports: Unomedical Devices De C V. Product code FPA.
- 2,169
- device reports naming the brand
- 0% of all MAUDE reports · about 2,169 a year
- 2,149
- reports, 12 months to August 2026
- 20 in the 12 months before
- 57.7%
- classified as malfunction
- 79.3% across the product code
- 0.6%
- classified as death, as reported
- 12 reports · not verified by FDA
FDA's MAUDE database holds 2,169 reports that name the brand "Comfort" (set administration intravascular), received between August 2025 and August 2026; the manufacturer given most often on reports is Unomedical Devices De C V. Spellings of one product vary from report to report.
2,149 reports arrived in the 12 months to August 2026, up 10645% from 20 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 (57.7%), injury (41.7%) and death (0.6%); across all set, administration, intravascular reports (product code FPA) death is recorded in 0.2% and malfunction in 79.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are premature separation (21.5%), loss of or failure to bond (19.9%) and leak/splash (11.8%). The patient problems coded most often are hyperglycemia, hypoglycemia and elevated ketones/ diabetic ketoacidosis. 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."
Reports by month, five years
Reports by the month FDA received them. 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, as classified on the report
Who filed the report
Grey bar: all 349,387 reports carrying product code FPA. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Premature separation | 466 | 21.5% | 13.4% |
| Loss of or failure to bond | 431 | 19.9% | 14% |
| Leak/splashthe device leaked | 255 | 11.8% | 11.2% |
| Use of incorrect control/treatment settings | 182 | 8.4% | 3.4% |
| Fluid/blood leak | 147 | 6.8% | 13.5% |
| Material twisted/bent | 144 | 6.6% | 12.2% |
| Complete blockage | 137 | 6.3% | 4.2% |
| Device handling problem | 108 | 5% | 1.4% |
| Detachment of device or device componentpart of the device came off | 96 | 4.4% | 3.9% |
| Partial blockage | 73 | 3.4% | 1.6% |
| Infusion or flow problema problem with flow or infusion | 48 | 2.2% | 3% |
| Deformation due to compressive stress | 24 | 1.1% | 0.2% |
| Failure to fire | 15 | 0.7% | 0.3% |
| Biocompatibility | 13 | 0.6% | 0.1% |
| Improper or incorrect procedure or method | 13 | 0.6% | 0.4% |
| Loose or intermittent connection | 10 | 0.5% | 0.5% |
| Incomplete or missing packaging | 8 | 0.4% | 0% |
| Protective measures problem | 7 | 0.3% | 0.1% |
| Tear, rip or hole in device packaging | 6 | 0.3% | 0.2% |
| Difficult to insertthe device was hard to insert | 5 | 0.2% | 0.1% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Hyperglycemiahigh blood sugar | 827 | 38.1% |
| Hypoglycemialow blood sugar | 91 | 4.2% |
| Elevated ketones/ diabetic ketoacidosis | 60 | 2.8% |
| Skin infection | 24 | 1.1% |
| Hemorrhage/blood loss/bleeding | 21 | 1% |
| Abscessa collection of pus | 12 | 0.6% |
| Painpain, site not specified | 10 | 0.5% |
| Itching sensation | 5 | 0.2% |
| Fatiguetiredness | 4 | 0.2% |
| Confusion/ disorientation | 3 | 0.1% |
| Discomfortdiscomfort | 3 | 0.1% |
| Local reaction | 3 | 0.1% |
| Nauseafeeling sick | 3 | 0.1% |
| Skin inflammation/ irritation | 3 | 0.1% |
| Coma | 2 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Comfort | Product code FPA | All MAUDE reports |
|---|---|---|---|
| Reports | 2,169 | 349,387 | 26,136,888 |
| Share of that pool | — | 0.6% | 0% |
| Classified as death, per 1,000 reports | 6 | 2 | 9 |
| Classified as injury | 41.7% | 20% | 36.2% |
| Classified as malfunction | 57.7% | 79.3% | 62.3% |
| Filed by the manufacturer | 100% | 96.3% | 94.9% |
Shares are of reports, not of devices in use. 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."
Other brands with product code FPA
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Inset Guard | 47,276 | 47,222 | 0.1% |
| Inset | 26,405 | 25,656 | 0% |
| Quick Set | 23,351 | 23,028 | 0.4% |
| Autosoft Xc | 20,328 | 49 | 0% |
| Autosoft 90 | 12,143 | 15 | 0% |
| Access | 14,160 | 0 | 0% |
| Other Accessories | 10,429 | 10,425 | 1.7% |
| Alaris Pump Module Administration Set | 8,492 | 0 | 0.2% |
| Contact Detach | 6,473 | 6,157 | 0.1% |
| Inset 30 | 3,528 | 3,461 | 0% |
| Cadd | 10,811 | 9 | 0.1% |
| Minimed Quick-Set | 3,101 | 6 | 0% |
| Cleo 90 Infusion Set | 3,006 | 23 | 0% |
| Trusteel | 2,886 | 14 | 0% |
| Autosoft 30 | 2,374 | 1 | 0% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Comfort reports
How many FDA reports name Comfort?
2,169 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 2,149 in the latest 12 months.
What kinds of events are reported?
malfunction (57.7%), injury (41.7%) and death (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
premature separation (21.5%), loss of or failure to bond (19.9%), leak/splash (11.8%), use of incorrect control/treatment settings (8.4%) and fluid/blood leak (6.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Comfort was at fault?
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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.