Catheter, conduction, anesthetic: medical device reports filed with FDA

2,613 reports carry this product code, 1992–2026; 18 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

2,613
reports with this product code: 0% of all MAUDE reports; 197
reports, 12 months to August 2026: 112 in the 12 months before; 74.1%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

Product code BSO is FDA's classification for "Catheter, conduction, anesthetic" (anesthesiology panel), a class 2 device. 2,613 medical device reports carry this product code, 0% of the MAUDE database, from July 1992 to August 2026.

197 reports arrived in the 12 months to August 2026, up 76% from 112 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 (74.1%), injury (18.3%) and other (6.8%). 18 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

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Epidural Catheterization Kit	662	3	0%	91.2%
Epidural Catheterization Set	131	29	0%	94.9%
Perifix	115	42	0%	76.2%
Arrow Epidural Catheterization Set	114	80	0%	95.7%
Arrow Epidural Catheterization Kit	55	15	0%	94.6%
On-Q Silversoaker	31	0	0.7%	4%
Catheter	28	9	3.7%	27.9%
Unknown Catheter	22	26	2.2%	38.1%
Indura	18	0	0.8%	31.6%
Arrow	9	65	3.4%	66.7%
Portex	6	8	0.6%	80.6%
Braun	3	24	0.5%	71.8%
Synchromed	3	3	3.2%	35.2%
Avanos	2	38	1.2%	91.2%
AirLife	1	37	2.6%	61.3%
B Braun	1	12	3%	77.8%
Jelco	1	34	0%	84.3%
On-Q Painbuster	1	0	0.6%	4.3%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Arrow International	1,294	49.5%
I-Flow	217	8.3%
B Braun Medical	94	3.6%
Avanos Medical	73	2.8%
B Braun Melsungen	69	2.6%
Arrow Intl	19	0.7%
Bard Access Systems	18	0.7%
Teleflex	15	0.6%
Smiths Medical Asd	12	0.5%
Rice Creek Manufacturing	11	0.4%
Bd	9	0.3%
Becton Dickinson	6	0.2%
Smith & Nephew Endoscopy Division	6	0.2%
Medtronic	5	0.2%
Smiths Medical International	5	0.2%

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

Death0.3%9

Injury18.3%479

Malfunction74.1%1,937

Other6.8%177

Not given0.4%11

Who filed

Manufacturer report86.6%2,263

Voluntary report5.9%155

User facility report0%0

Distributor report0.1%3

Not given7.3%192

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	1,115	42.7%
Difficult to removethe device was hard to remove	229	8.8%
Material twisted/bent	164	6.3%
Device, or device fragments remain in patient	137	5.2%
Fluid/blood leak	115	4.4%
Material separation	105	4%
Detachment of device component	100	3.8%
Obstruction of flow	95	3.6%
Tip breakage	92	3.5%
Detachment of device or device componentpart of the device came off	77	2.9%
Difficult to advance	69	2.6%
Physical resistance	63	2.4%
No flow	51	2%
Material fragmentation	44	1.7%
Stretched	39	1.5%
Failure to advance	35	1.3%
Physical resistance/sticking	35	1.3%
Fracturea broken bone	33	1.3%
Leak/splashthe device leaked	32	1.2%
Device or device fragments location unknown	28	1.1%

Questions about catheter, conduction, anesthetic reports

What is product code BSO?

FDA's classification code for "Catheter, conduction, anesthetic", class 2, reviewed by the anesthesiology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

2,613 reports through August 2026, 197 of them in the latest 12 months.

Which brands appear most often?

Epidural Catheterization Kit (662), Epidural Catheterization Set (131), Perifix (115), Arrow Epidural Catheterization Set (114) and Arrow Epidural Catheterization Kit (55). 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.