Reported Reactions

Devices › Catheter, percutaneous

Device brand name · Catheter percutaneous

Arrow Cvc Set 16 Ga X 8 20 Cm: medical device reports filed with FDA

551 reports name it, 2017–2025. Manufacturer given most often on reports: Arrow International. Product code DQY.

551
device reports naming the brand
0% of all MAUDE reports · about 60 a year
0
reports, 12 months to August 2026
43 in the 12 months before
99.8%
classified as malfunction
74.7% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 551 reports that name the brand "Arrow Cvc Set 16 Ga X 8 20 Cm" (catheter percutaneous), received between April 2017 and July 2025; the manufacturer given most often on reports is Arrow International. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, against 43 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 (99.8%) and injury (0.2%); across all catheter, percutaneous reports (product code DQY) death is recorded in 2.2% and malfunction in 74.7%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are leak/splash (40.3%), deformation due to compressive stress (13.6%) and material deformation (11.3%). The patient problems coded most often are no patient involvement, pain and anaphylactic shock. 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

01019Sep 2021: 9Oct 2021: 10Nov 2021: 13Dec 2021: 32022Jan 2022: 5Feb 2022: 1Mar 2022: 6Apr 2022: 7May 2022: 19Jun 2022: 7Jul 2022: 3Aug 2022: 5Sep 2022: 11Oct 2022: 17Nov 2022: 18Dec 2022: 102023Jan 2023: 7Feb 2023: 1Mar 2023: 8Apr 2023: 15May 2023: 10Jun 2023: 16Jul 2023: 13Aug 2023: 10Sep 2023: 8Oct 2023: 3Nov 2023: 2Dec 2023: 102024Jan 2024: 0Feb 2024: 2Mar 2024: 3Apr 2024: 1May 2024: 0Jun 2024: 1Jul 2024: 3Aug 2024: 1Sep 2024: 16Oct 2024: 0Nov 2024: 2Dec 2024: 12025Jan 2025: 6Feb 2025: 2Mar 2025: 5Apr 2025: 3May 2025: 3Jun 2025: 2Jul 2025: 3Aug 2025: 0Sep 2025: 0Oct 2025: 0Nov 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

0551092017: 1020172018: 8020182019: 7120192020: 5020202021: 7420212022: 10920222023: 10320232024: 3020242025: 242025

Event type and report source

Event type, as classified on the report

Death0%0
Injury0.2%1
Malfunction99.8%550
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%551
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 41,793 reports carrying product code DQY. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Leak/splashthe device leaked22240.3%4.6%
Deformation due to compressive stress7513.6%2.3%
Material deformation6211.3%5%
Fluid/blood leak386.9%2.1%
Material twisted/bent356.4%2.4%
Physical resistance/sticking285.1%2.9%
Fitting problem213.8%0.1%
Crackthe device cracked173.1%1.8%
Material separation173.1%4.1%
Device damaged prior to usethe device was damaged before use142.5%1.8%
Kinkedthe tube or line kinked112%3.4%
Material too soft/flexible81.5%0%
Difficult to advance71.3%1.8%
Obstruction of flow71.3%0.6%
Off-label use61.1%0%
Breakthe device broke50.9%9.2%
Connection problema connection problem50.9%0.3%
Complete blockage40.7%0.2%
Gas/air leak40.7%0.2%
Loose or intermittent connection40.7%0.1%

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
No patient involvement173.1%
Painpain, site not specified40.7%
Anaphylactic shocka severe allergic reaction with collapse10.2%
Discomfortdiscomfort10.2%
Fever10.2%
Headachehead pain10.2%
Hematomaa collection of blood under the skin or in tissue10.2%
Needle stick/puncture10.2%

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

In context

MeasureArrow Cvc Set 16 Ga X 8 20 CmProduct code DQYAll MAUDE reports
Reports55141,79326,136,888
Share of that pool—1.3%0%
Classified as death, per 1,000 reports0229
Classified as injury0.2%22.7%36.2%
Classified as malfunction99.8%74.7%62.3%
Filed by the manufacturer100%97.4%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 DQY

BrandReportsLatest 12 monthsClassified as death
Sterling4,9633000.1%
Deflect1,0212470.1%
Guidezilla1,01800%
Lantern Delivery Microcatheter887190%
WATCHMAN FXD Curve Access System9731989.6%
Arrow Cvc Set 2-Lumen 7 Fr X 20 Cm1,4061700.1%
Coyote?1,7671220.1%
Advance 35 Lp Low Profile Balloon Catheter572150.5%
Conquest Pta Dilatation Catheter50500.2%
WATCHMAN TruSeal Access System716508%
Sterling Balloon Dilatation Catheter48800.4%
React catheter5164118.4%
Conquest Pta Balloon Dilatation Catheter51000.2%
Arrow Cvc Set 3-Lumen 7 Fr X 20 Cm1,1101230.1%
Neuron Max 6f 088 Long Sheath38900.5%

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 Cvc Set 16 Ga X 8 20 Cm reports

How many FDA reports name Arrow Cvc Set 16 Ga X 8 20 Cm?

551 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (99.8%) and injury (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

leak/splash (40.3%), deformation due to compressive stress (13.6%), material deformation (11.3%), fluid/blood leak (6.9%) and material twisted/bent (6.4%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Arrow Cvc Set 16 Ga X 8 20 Cm 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.