Devices › Catheter, intravascular, therapeutic, short-term less than 30 days
Device brand name · Peripheral iv catheters
BD Insyte Autoguard: medical device reports filed with FDA
1,246 reports name it, 2001–2026. Manufacturer given most often on reports: Becton Dickinson Infusion Therapy Systems. Product code FOZ.
- 1,246
- device reports naming the brand
- 0% of all MAUDE reports · about 49 a year
- 55
- reports, 12 months to August 2026
- 555 in the 12 months before
- 93.7%
- classified as malfunction
- 83.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 1,246 reports that name the brand "BD Insyte Autoguard" (peripheral iv catheters), received between February 2001 and August 2026; the manufacturer given most often on reports is Becton Dickinson Infusion Therapy Systems. Spellings of one product vary from report to report.
55 reports arrived in the 12 months to August 2026, down 90% from 555 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 (93.7%), injury (5.2%) and other (1%); 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 (37.6%), leak/splash (6.2%) and fluid/blood leak (5%). The patient problems coded most often are foreign body in patient, needle stick/puncture and pain. 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 | 469 | 37.6% | 9% |
| Leak/splashthe device leaked | 77 | 6.2% | 21.4% |
| Fluid/blood leak | 62 | 5% | 6.7% |
| Defective component | 57 | 4.6% | 2.6% |
| Material puncture/hole | 56 | 4.5% | 2.3% |
| Breakthe device broke | 44 | 3.5% | 10.9% |
| Device contamination with chemical or other material | 41 | 3.3% | 5.9% |
| Material split, cut or torn | 40 | 3.2% | 1.5% |
| Defective devicethe device was defective | 16 | 1.3% | 0.7% |
| Failure to advance | 16 | 1.3% | 0.7% |
| Material frayed | 15 | 1.2% | 1% |
| Crackthe device cracked | 14 | 1.1% | 2.1% |
| Premature separation | 12 | 1% | 0.3% |
| Bent | 11 | 0.9% | 0.5% |
| Device markings/labelling problema problem with the device markings or label | 11 | 0.9% | 0.5% |
| Material protrusion/extrusion | 10 | 0.8% | 1.4% |
| Material separation | 9 | 0.7% | 4.2% |
| Material twisted/bent | 9 | 0.7% | 1.7% |
| Mechanical problema mechanical problem | 8 | 0.6% | 0.2% |
| Detachment of device or device componentpart of the device came off | 7 | 0.6% | 1.3% |
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 |
|---|---|---|
| Foreign body in patientpart of a device left in the patient | 29 | 2.3% |
| Needle stick/puncture | 29 | 2.3% |
| Painpain, site not specified | 18 | 1.4% |
| Perforation of vessels | 12 | 1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 11 | 0.9% |
| Hemorrhage/blood loss/bleeding | 7 | 0.6% |
| Skin inflammation/ irritation | 7 | 0.6% |
| Therapy/non-surgical treatment, additional | 7 | 0.6% |
| No patient involvement | 6 | 0.5% |
| Discomfortdiscomfort | 5 | 0.4% |
| Extravasation | 5 | 0.4% |
| Infiltration into tissue | 5 | 0.4% |
| Foreign body, removal of | 4 | 0.3% |
| Laceration(s) | 4 | 0.3% |
| Blood loss | 3 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | BD Insyte Autoguard | Product code FOZ | All MAUDE reports |
|---|---|---|---|
| Reports | 1,246 | 49,301 | 26,136,888 |
| Share of that pool | — | 2.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 5.2% | 13.1% | 36.2% |
| Classified as malfunction | 93.7% | 83.5% | 62.3% |
| Filed by the manufacturer | 68.1% | 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 |
|---|---|---|---|
| Insyte AUTOGUARD | 1,314 | 1,050 | 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 BD Insyte Autoguard reports
How many FDA reports name BD Insyte Autoguard?
1,246 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 55 in the latest 12 months.
What kinds of events are reported?
malfunction (93.7%), injury (5.2%) and other (1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
retraction problem (37.6%), leak/splash (6.2%), fluid/blood leak (5%), defective component (4.6%) and material puncture/hole (4.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (68.1%) and voluntary reports (6.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that BD 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.