Devices › Catheter, intravascular, therapeutic, short-term less than 30 days
Device brand name · Peripheral iv catheters
Insyte AUTOGUARD: medical device reports filed with FDA
1,314 reports name it, 1997–2026. Manufacturer given most often on reports: Becton Dickinson Infusion Therapy Systems. Product code FOZ.
- 1,314
- device reports naming the brand
- 0% of all MAUDE reports · about 45 a year
- 1,050
- reports, 12 months to August 2026
- 97 in the 12 months before
- 95.4%
- classified as malfunction
- 83.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
1,314 medical device reports received by FDA name the brand "Insyte AUTOGUARD" (peripheral iv catheters); the manufacturer given most often on reports is Becton Dickinson Infusion Therapy Systems; received from March 1997 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
1,050 reports arrived in the 12 months to August 2026, up 982% from 97 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 (95.4%), injury (3.7%) and other (0.4%); across all catheter, intravascular, therapeutic, short-term less than 30 days reports (product code FOZ) death is recorded in 0.3% and malfunction in 83.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are retraction problem (50.5%), leak/splash (10.8%) and material puncture/hole (5.6%). The patient problems coded most often are pain, needle stick/puncture and foreign body in patient. 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.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 49,301 reports carrying product code FOZ. 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 |
|---|---|---|---|
| Retraction problem | 663 | 50.5% | 9% |
| Leak/splashthe device leaked | 142 | 10.8% | 21.4% |
| Material puncture/hole | 73 | 5.6% | 2.3% |
| Material integrity problema problem with the device material | 56 | 4.3% | 0.8% |
| Breakthe device broke | 53 | 4% | 10.9% |
| Material split, cut or torn | 46 | 3.5% | 1.5% |
| Contamination | 41 | 3.1% | 1% |
| Fluid/blood leak | 34 | 2.6% | 6.7% |
| Product quality problem | 21 | 1.6% | 0.5% |
| Contamination /decontamination problem | 19 | 1.4% | 0.7% |
| Material perforation | 19 | 1.4% | 0.3% |
| Activation problem | 18 | 1.4% | 1% |
| Difficult to advance | 18 | 1.4% | 0.7% |
| Nonstandard device | 18 | 1.4% | 0.4% |
| Activation, positioning or separation problem | 16 | 1.2% | 0.7% |
| Connection problema connection problem | 15 | 1.1% | 0.3% |
| Material protrusion/extrusion | 15 | 1.1% | 1.4% |
| Difficult to insertthe device was hard to insert | 14 | 1.1% | 1.2% |
| Material frayed | 13 | 1% | 1% |
| Material separation | 12 | 0.9% | 4.2% |
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 |
|---|---|---|
| Painpain, site not specified | 28 | 2.1% |
| Needle stick/puncture | 26 | 2% |
| Foreign body in patientpart of a device left in the patient | 22 | 1.7% |
| Perforation of vessels | 22 | 1.7% |
| Extravasation | 11 | 0.8% |
| Swelling/ edema | 10 | 0.8% |
| Discomfortdiscomfort | 9 | 0.7% |
| Necrosisdeath of tissue | 6 | 0.5% |
| Venipuncture | 6 | 0.5% |
| Ecchymosis | 4 | 0.3% |
| Exposure to body fluids | 4 | 0.3% |
| Skin inflammation/ irritation | 3 | 0.2% |
| Abrasion | 2 | 0.2% |
| Bruise/contusion | 2 | 0.2% |
| Hematomaa collection of blood under the skin or in tissue | 2 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Insyte AUTOGUARD | Product code FOZ | All MAUDE reports |
|---|---|---|---|
| Reports | 1,314 | 49,301 | 26,136,888 |
| Share of that pool | — | 2.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 3.7% | 13.1% | 36.2% |
| Classified as malfunction | 95.4% | 83.5% | 62.3% |
| Filed by the manufacturer | 87.4% | 89.6% | 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 FOZ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| BD Insyte Autoguard | 1,246 | 55 | 0% |
| Introcan Safety | 1,255 | 45 | 0.1% |
| Bd Insyte Autog Bc | 695 | 0 | 0% |
| Arrow Cvc Set 3-Lumen 7 Fr X 20 Cm | 1,110 | 123 | 0.1% |
| Arrow Cvc Set 2-Lumen 7 Fr X 20 Cm | 1,406 | 170 | 0.1% |
| Nexiva | 385 | 304 | 0% |
| Mahurkar | 1,046 | 6 | 1.1% |
| BD Nexiva | 372 | 14 | 0% |
| Jelco | 363 | 34 | 0% |
| Arrow Pi Cvc Kit 3-L 7 Fr X 20 Cm Agb | 286 | 63 | 1% |
| Arrow Cvc Set 16 Ga X 8 20 Cm | 551 | 0 | 0% |
| Arrow Cvc Set 3-Lumen 7 Fr X 30 Cm | 338 | 12 | 0% |
| Bd Nexiva Single Port | 224 | 0 | 0% |
| Unspecified Bd Catheter | 251 | 0 | 0% |
| Accu-Chek Tender Infusion Set | 839 | 0 | 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 Insyte AUTOGUARD reports
How many FDA reports name Insyte AUTOGUARD?
1,314 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1,050 in the latest 12 months.
What kinds of events are reported?
malfunction (95.4%), injury (3.7%) and other (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
retraction problem (50.5%), leak/splash (10.8%), material puncture/hole (5.6%), material integrity problem (4.3%) and break (4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (87.4%) and voluntary reports (2.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Insyte AUTOGUARD 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.