Devices › Catheter, intravascular, therapeutic, short-term less than 30 days
Device brand name · Catheter intravascular therape
Arrow Cvc Set 3-Lumen 7 Fr X 30 Cm: medical device reports filed with FDA
338 reports name it, 2016–2026. Manufacturer given most often on reports: Arrow International. Product code FOZ.
- 338
- device reports naming the brand
- 0% of all MAUDE reports · about 35 a year
- 12
- reports, 12 months to August 2026
- 21 in the 12 months before
- 98.2%
- classified as malfunction
- 83.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 338 reports that name the brand "Arrow Cvc Set 3-Lumen 7 Fr X 30 Cm" (catheter intravascular therape), received between December 2016 and August 2026; the manufacturer given most often on reports is Arrow International. Spellings of one product vary from report to report.
12 reports arrived in the 12 months to August 2026, down 43% from 21 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 (98.2%) and injury (1.8%); across all catheter, intravascular, therapeutic, short-term less than 30 days reports (product code FOZ) death is recorded in 0.3% and malfunction in 83.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are material separation (23.4%), material deformation (11.2%) and deformation due to compressive stress (10.9%). The patient problems coded most often are no patient involvement, foreign body in patient and hematoma. 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
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
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 49,301 reports carrying product code FOZ. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Material separation | 79 | 23.4% | 4.2% |
| Material deformation | 38 | 11.2% | 2% |
| Deformation due to compressive stress | 37 | 10.9% | 1.7% |
| Fluid/blood leak | 37 | 10.9% | 6.7% |
| Breakthe device broke | 22 | 6.5% | 10.9% |
| Leak/splashthe device leaked | 22 | 6.5% | 21.4% |
| Physical resistance/sticking | 18 | 5.3% | 1% |
| Obstruction of flow | 17 | 5% | 0.5% |
| Material twisted/bent | 9 | 2.7% | 1.7% |
| Detachment of device or device componentpart of the device came off | 8 | 2.4% | 1.3% |
| Unraveled material | 8 | 2.4% | 1.7% |
| Kinkedthe tube or line kinked | 6 | 1.8% | 1.5% |
| Crackthe device cracked | 5 | 1.5% | 2.1% |
| Device damaged prior to usethe device was damaged before use | 5 | 1.5% | 0.3% |
| Dull, blunt | 4 | 1.2% | 0.5% |
| Fitting problem | 4 | 1.2% | 0.2% |
| Air/gas in device | 3 | 0.9% | 0.1% |
| Complete blockage | 3 | 0.9% | 0.4% |
| Difficult to insertthe device was hard to insert | 3 | 0.9% | 1.2% |
| Difficult to removethe device was hard to remove | 3 | 0.9% | 1.8% |
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) | Reports | Share |
|---|---|---|
| No patient involvement | 5 | 1.5% |
| Foreign body in patientpart of a device left in the patient | 2 | 0.6% |
| Hematomaa collection of blood under the skin or in tissue | 2 | 0.6% |
| Hemorrhage/blood loss/bleeding | 2 | 0.6% |
| Hypersensitivity/allergic reaction | 2 | 0.6% |
| Blood loss | 1 | 0.3% |
| Brain injury | 1 | 0.3% |
| Device embedded in tissue or plaque | 1 | 0.3% |
| Dyspneashortness of breath | 1 | 0.3% |
| Infiltration into tissue | 1 | 0.3% |
| Loss of consciousnesspassing out | 1 | 0.3% |
| Low blood pressure/ hypotension | 1 | 0.3% |
| Low oxygen saturation | 1 | 0.3% |
| Painpain, site not specified | 1 | 0.3% |
| Swelling/ edema | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Arrow Cvc Set 3-Lumen 7 Fr X 30 Cm | Product code FOZ | All MAUDE reports |
|---|---|---|---|
| Reports | 338 | 49,301 | 26,136,888 |
| Share of that pool | — | 0.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 1.8% | 13.1% | 36.2% |
| Classified as malfunction | 98.2% | 83.5% | 62.3% |
| Filed by the manufacturer | 100% | 89.6% | 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 FOZ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Insyte AUTOGUARD | 1,314 | 1,050 | 0% |
| BD Insyte Autoguard | 1,246 | 55 | 0% |
| Introcan Safety | 1,255 | 45 | 0.1% |
| Bd Insyte Autog Bc | 695 | 0 | 0% |
| Arrow Cvc Set 3-Lumen 7 Fr X 20 Cm | 1,110 | 123 | 0.1% |
| Arrow Cvc Set 2-Lumen 7 Fr X 20 Cm | 1,406 | 170 | 0.1% |
| Nexiva | 385 | 304 | 0% |
| Mahurkar | 1,046 | 6 | 1.1% |
| BD Nexiva | 372 | 14 | 0% |
| Jelco | 363 | 34 | 0% |
| Arrow Pi Cvc Kit 3-L 7 Fr X 20 Cm Agb | 286 | 63 | 1% |
| Arrow Cvc Set 16 Ga X 8 20 Cm | 551 | 0 | 0% |
| Bd Nexiva Single Port | 224 | 0 | 0% |
| Unspecified Bd Catheter | 251 | 0 | 0% |
| Accu-Chek Tender Infusion Set | 839 | 0 | 0% |
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 3-Lumen 7 Fr X 30 Cm reports
How many FDA reports name Arrow Cvc Set 3-Lumen 7 Fr X 30 Cm?
338 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 (98.2%) and injury (1.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material separation (23.4%), material deformation (11.2%), deformation due to compressive stress (10.9%), fluid/blood leak (10.9%) and break (6.5%). 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 Arrow Cvc Set 3-Lumen 7 Fr X 30 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.