Epidural anesthesia kit: medical device reports filed with FDA

1,134 reports carry this product code, 2008–2026; 8 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.

1,134
reports with this product code: 0% of all MAUDE reports; 69
reports, 12 months to August 2026: 95 in the 12 months before; 91%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code OGE is FDA's classification for "Epidural anesthesia kit" (anesthesiology panel), a class 2 device. 1,134 medical device reports carry this product code, 0% of the MAUDE database, from October 2008 to August 2026.

69 reports arrived in the 12 months to August 2026, down 27% from 95 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%) and injury (8.8%). 8 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
Perifix	473	42	0%	76.2%
Design Options	136	11	0%	86.8%
Epidural Catheterization Set	83	29	0%	94.9%
Epidural Catheterization Kit	78	3	0%	91.2%
Arrow Epidural Catheterization Kit	65	15	0%	94.6%
Arrow Epidural Catheterization Set	44	80	0%	95.7%
Braun	2	24	0.5%	71.8%
Pencan	1	17	0%	55.8%

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
B Braun Medical	492	43.4%
Arrow International	207	18.3%
B Braun Melsungen	207	18.3%
Arrow Intl	12	1.1%

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%0

Injury8.8%100

Malfunction91%1,032

Other0%0

Not given0.2%2

Who filed

Manufacturer report85.5%970

Voluntary report6.8%77

User facility report0%0

Distributor report0%0

Not given7.7%87

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	357	31.5%
Detachment of device or device componentpart of the device came off	240	21.2%
Fluid/blood leak	104	9.2%
Leak/splashthe device leaked	49	4.3%
Contamination /decontamination problem	32	2.8%
Difficult to advance	24	2.1%
Difficult to removethe device was hard to remove	22	1.9%
Difficult to position	17	1.5%
Failure to infuse	16	1.4%
Material fragmentation	15	1.3%
Material separation	14	1.2%
Material split, cut or torn	14	1.2%
Obstruction of flow	14	1.2%
Physical resistance	14	1.2%
Physical resistance/sticking	12	1.1%
Connection problema connection problem	11	1%
Loose or intermittent connection	11	1%
Device damaged prior to usethe device was damaged before use	10	0.9%
Infusion or flow problema problem with flow or infusion	10	0.9%
Fracturea broken bone	8	0.7%

Questions about epidural anesthesia kit reports

What is product code OGE?

FDA's classification code for "Epidural anesthesia kit", class 2, reviewed by the anesthesiology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

1,134 reports through August 2026, 69 of them in the latest 12 months.

Which brands appear most often?

Perifix (473), Design Options (136), Epidural Catheterization Set (83), Epidural Catheterization Kit (78) and Arrow Epidural Catheterization Kit (65). 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.