Reported Reactions

Devices › Catheter, percutaneous

Device brand name · Arrowg+ard catheter products

Cvc Set 3-Lumen 7 Fr X 20 Cm: medical device reports filed with FDA

280 reports name it, 2008–2024. Manufacturer given most often on reports: Arrow International. Product code DQY.

280
device reports naming the brand
0% of all MAUDE reports · about 15 a year
0
reports, 12 months to August 2026
0 in the 12 months before
95.4%
classified as malfunction
74.7% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

280 medical device reports received by FDA name the brand "Cvc Set 3-Lumen 7 Fr X 20 Cm" (arrowg+ard catheter products); the manufacturer given most often on reports is Arrow International; received from January 2008 to July 2024. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

0 reports arrived in the 12 months to August 2026, and 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 (95.4%) and injury (4.3%); 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 kinked (44.3%), physical resistance (13.6%) and leak/splash (8.9%). The patient problems coded most often are injury, low blood pressure/ hypotension and no patient involvement. 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

035Sep 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: 3Feb 2024: 2Mar 2024: 2Apr 2024: 0May 2024: 5Jun 2024: 3Jul 2024: 2Aug 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: 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

040792008: 620082013: 2920132014: 7120142015: 7520152016: 7920162019: 320192024: 172024

Event type and report source

Event type, as classified on the report

Death0%0
Injury4.3%12
Malfunction95.4%267
Other0%0
Not given0.4%1

Who filed the report

Manufacturer report100%280
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
Kinkedthe tube or line kinked12444.3%3.4%
Physical resistance3813.6%1.3%
Leak/splashthe device leaked258.9%4.6%
Crackthe device cracked217.5%1.8%
Unraveled material217.5%2.1%
Material separation124.3%4.1%
Material deformation113.9%5%
Split93.2%0.2%
Breakthe device broke72.5%9.2%
Fluid/blood leak72.5%2.1%
Stretched72.5%0.5%
Bent51.8%0.4%
Material twisted/bent51.8%2.4%
Difficult to advance41.4%1.8%
Fracturea broken bone41.4%2.6%
Loose or intermittent connection41.4%0.1%
Deformation due to compressive stress31.1%2.3%
Physical resistance/sticking31.1%2.9%
Detachment of device or device componentpart of the device came off20.7%4.6%
Air leak10.4%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
Injurya physical injury31.1%
Low blood pressure/ hypotension20.7%
No patient involvement20.7%
Vessel or plaque, device embedded in20.7%
Blood loss10.4%
Deaththe patient died; cause not stated by this term10.4%
Device embedded in tissue or plaque10.4%
Embolism10.4%
Foreign body in patientpart of a device left in the patient10.4%

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

In context

MeasureCvc Set 3-Lumen 7 Fr X 20 CmProduct code DQYAll MAUDE reports
Reports28041,79326,136,888
Share of that pool—0.7%0%
Classified as death, per 1,000 reports0229
Classified as injury4.3%22.7%36.2%
Classified as malfunction95.4%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 Cvc Set 3-Lumen 7 Fr X 20 Cm reports

How many FDA reports name Cvc Set 3-Lumen 7 Fr X 20 Cm?

280 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 (95.4%) and injury (4.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

kinked (44.3%), physical resistance (13.6%), leak/splash (8.9%), crack (7.5%) and unraveled material (7.5%). 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 Cvc Set 3-Lumen 7 Fr X 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.