Reported Reactions

Devices › Anesthesia conduction kit

Device brand name · Epidural catheter kit

Arrow Epidural Anesthesia Kit: medical device reports filed with FDA

154 reports name it, 1997–2025. Manufacturer given most often on reports: Arrow International. Product code CAZ.

154
device reports naming the brand
0% of all MAUDE reports · about 5 a year
12
reports, 12 months to August 2026
0 in the 12 months before
53.2%
classified as malfunction
69% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

154 medical device reports received by FDA name the brand "Arrow Epidural Anesthesia Kit" (epidural catheter kit); the manufacturer given most often on reports is Arrow International; received from January 1997 to October 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

12 reports arrived in the 12 months to August 2026, with none 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 (53.2%) and injury (46.1%); across all anesthesia conduction kit reports (product code CAZ) death is recorded in 0.1% and malfunction in 69%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are material separation (70.8%), difficult to remove (48.1%) and device, or device fragments remain in patient (47.4%). The patient problems coded most often are nonresorbable materials, unretrieved in body, surgical procedure and foreign body, removal of. 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

0612Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 0Aug 2022: 0Sep 2022: 0Oct 2022: 0Nov 2022: 0Dec 2022: 02023Jan 2023: 0Feb 2023: 0Mar 2023: 0Apr 2023: 0May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 0Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 02024Jan 2024: 0Feb 2024: 0Mar 2024: 0Apr 2024: 0May 2024: 0Jun 2024: 0Jul 2024: 0Aug 2024: 0Sep 2024: 0Oct 2024: 0Nov 2024: 0Dec 2024: 02025Jan 2025: 0Feb 2025: 0Mar 2025: 0Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 12Nov 2025: 0Dec 2025: 02026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0Jul 2026: 0Aug 2026: 0

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

017341997: 1519971998: 3219981999: 3419992000: 1720002001: 1620012002: 1620022003: 920032004: 320042025: 122025

Event type and report source

Event type, as classified on the report

Death0%0
Injury46.1%71
Malfunction53.2%82
Other0%0
Not given0.6%1

Who filed the report

Manufacturer report99.4%153
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0.6%1

Grey bar: all 5,156 reports carrying product code CAZ. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Material separation10970.8%7%
Difficult to removethe device was hard to remove7448.1%8.1%
Device, or device fragments remain in patient7347.4%7.5%
Breakthe device broke1912.3%19.3%
Physical resistance1610.4%3.2%
Detachment of device component106.5%3.2%
Tip breakage95.8%3.5%
Difficult to insertthe device was hard to insert74.5%2.2%
Stretched74.5%0.8%
Replace21.3%0.9%
Syringe, defective21.3%0.1%
Device or device fragments location unknown10.6%1%
Explanted10.6%0.2%
Failure to service10.6%0%
Leak/splashthe device leaked10.6%4.3%
Material fragmentation10.6%2.4%
Migration or expulsion of device10.6%0.1%
Other (for use when an appropriate device code cannot be identified)10.6%0.4%
Source, detachment from10.6%0%
Unraveled material10.6%0.7%

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)ReportsShare
Nonresorbable materials, unretrieved in body7347.4%
Surgical procedure2818.2%
Foreign body, removal of2013%
Therapy/non-surgical treatment, additional106.5%
Surgical procedure, additional63.9%
Painpain, site not specified31.9%
Perforation31.9%
Dural tear10.6%
Membrane, breakage of10.6%
Meningitis10.6%
Migrationthe device moved from where it was placed10.6%
Numbnessnumbness10.6%
Vessel or plaque, device embedded in10.6%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureArrow Epidural Anesthesia KitProduct code CAZAll MAUDE reports
Reports1545,15626,136,888
Share of that pool—3%0%
Classified as death, per 1,000 reports019
Classified as injury46.1%26.3%36.2%
Classified as malfunction53.2%69%62.3%
Filed by the manufacturer99.4%84.6%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 CAZ

BrandReportsLatest 12 monthsClassified as death
Epidural Catheterization Kit1,21730%
Epidural Catheterization Set545290%
Portex Spinal Anesthesia Trays32300%
Perifix760420%
Arrow Epidural Catheterization Kit202150%
Custom Pak1,26200%
Arrow830653.4%
Portex97080.6%
Arrow Epidural Catheterization Set187800%
Pencan190170%
B Braun270123%
Design Options174110%
Bd19101%
Avanos170381.2%
Braun365240.5%

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 Arrow Epidural Anesthesia Kit reports

How many FDA reports name Arrow Epidural Anesthesia Kit?

154 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 12 in the latest 12 months.

What kinds of events are reported?

malfunction (53.2%) and injury (46.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

material separation (70.8%), difficult to remove (48.1%), device, or device fragments remain in patient (47.4%), break (12.3%) and physical resistance (10.4%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Arrow Epidural Anesthesia 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.