Devices › Catheter, conduction, anesthetic
Device brand name · Anesthesia conduction catheter
Epidural Catheterization Kit: medical device reports filed with FDA
1,217 reports name it, 2005–2025. Manufacturer given most often on reports: Arrow International. Product code BSO.
- 1,217
- device reports naming the brand
- 0% of all MAUDE reports · about 57 a year
- 3
- reports, 12 months to August 2026
- 1 in the 12 months before
- 91.2%
- classified as malfunction
- 74.1% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 1,217 reports that name the brand "Epidural Catheterization Kit" (anesthesia conduction catheter), received between January 2005 and October 2025; the manufacturer given most often on reports is Arrow International. Spellings of one product vary from report to report.
3 reports arrived in the 12 months to August 2026, up 200% from 1 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 (91.2%) and injury (8.7%); across all catheter, conduction, anesthetic reports (product code BSO) death is recorded in 0.3% and malfunction in 74.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (49.9%), difficult to advance (8.3%) and fluid/blood leak (4.8%). The patient problems coded most often are no patient involvement, headache, lumbar puncture and not applicable. 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 2,613 reports carrying product code BSO. 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 |
|---|---|---|---|
| Breakthe device broke | 607 | 49.9% | 42.7% |
| Difficult to advance | 101 | 8.3% | 2.6% |
| Fluid/blood leak | 58 | 4.8% | 4.4% |
| Physical resistance | 45 | 3.7% | 2.4% |
| Bent | 42 | 3.5% | 0.1% |
| Leak/splashthe device leaked | 35 | 2.9% | 1.2% |
| Material separation | 35 | 2.9% | 4% |
| Difficult to removethe device was hard to remove | 28 | 2.3% | 8.8% |
| Material twisted/bent | 28 | 2.3% | 6.3% |
| Activation, positioning or separation problem | 17 | 1.4% | 0.3% |
| Obstruction of flow | 17 | 1.4% | 3.6% |
| Device, or device fragments remain in patient | 16 | 1.3% | 5.2% |
| Failure to advance | 16 | 1.3% | 1.3% |
| Infusion or flow problema problem with flow or infusion | 16 | 1.3% | 0% |
| Physical resistance/sticking | 14 | 1.2% | 1.3% |
| No flow | 13 | 1.1% | 2% |
| Crackthe device cracked | 12 | 1% | 0.5% |
| Device contamination with chemical or other material | 11 | 0.9% | 0% |
| Cut in material | 8 | 0.7% | 0.2% |
| Material fragmentation | 7 | 0.6% | 1.7% |
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 |
|---|---|---|
| No patient involvement | 468 | 38.5% |
| Headache, lumbar puncture | 28 | 2.3% |
| Not applicable | 25 | 2.1% |
| Device embedded in tissue or plaque | 20 | 1.6% |
| Nonresorbable materials, unretrieved in body | 16 | 1.3% |
| Foreign body in patientpart of a device left in the patient | 12 | 1% |
| Therapy/non-surgical treatment, additional | 9 | 0.7% |
| Painpain, site not specified | 5 | 0.4% |
| Foreign body, removal of | 4 | 0.3% |
| Hemorrhage/blood loss/bleeding | 2 | 0.2% |
| Other (for use when an appropriate patient code cannot be identified) | 2 | 0.2% |
| Perforation | 2 | 0.2% |
| Surgical procedure | 2 | 0.2% |
| Embolism | 1 | 0.1% |
| Fistula | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Epidural Catheterization Kit | Product code BSO | All MAUDE reports |
|---|---|---|---|
| Reports | 1,217 | 2,613 | 26,136,888 |
| Share of that pool | — | 46.6% | 0% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 8.7% | 18.3% | 36.2% |
| Classified as malfunction | 91.2% | 74.1% | 62.3% |
| Filed by the manufacturer | 99.4% | 86.6% | 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 BSO
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Epidural Catheterization Set | 545 | 29 | 0% |
| Perifix | 760 | 42 | 0% |
| Arrow Epidural Catheterization Set | 187 | 80 | 0% |
| Arrow Epidural Catheterization Kit | 202 | 15 | 0% |
| On-Q Silversoaker | 151 | 0 | 0.7% |
| Catheter | 244 | 9 | 3.7% |
| Unknown Catheter | 270 | 26 | 2.2% |
| Indura | 2,730 | 0 | 0.8% |
| Arrow | 830 | 65 | 3.4% |
| Portex | 970 | 8 | 0.6% |
| Braun | 365 | 24 | 0.5% |
| Synchromed | 3,429 | 3 | 3.2% |
| Avanos | 170 | 38 | 1.2% |
| AirLife | 155 | 37 | 2.6% |
| B Braun | 270 | 12 | 3% |
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 Epidural Catheterization Kit reports
How many FDA reports name Epidural Catheterization Kit?
1,217 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 3 in the latest 12 months.
What kinds of events are reported?
malfunction (91.2%) and injury (8.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (49.9%), difficult to advance (8.3%), fluid/blood leak (4.8%), physical resistance (3.7%) and bent (3.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.4%) and voluntary reports (0.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Epidural Catheterization Kit 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.