Reported Reactions

Devices › Catheter, intravascular, therapeutic, long-term greater than 30 days

Device brand name · Catheter intravascular therapeutic long-term greater than 30 days

Groshong Nxt Clearvue 4f Single-Lumen Basic Tray: medical device reports filed with FDA

246 reports name it, 2020–2025. Manufacturer given most often on reports: C R Bard Basd -3006260740. Product code LJS.

246
device reports naming the brand
0% of all MAUDE reports · about 43 a year
0
reports, 12 months to August 2026
30 in the 12 months before
91.1%
classified as malfunction
81.1% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 246 reports that name the brand "Groshong Nxt Clearvue 4f Single-Lumen Basic Tray" (catheter intravascular therapeutic long-term greater than 30 days), received between November 2020 and January 2025; the manufacturer given most often on reports is C R Bard Basd -3006260740. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, against 30 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 (91.1%) and injury (8.9%); across all catheter, intravascular, therapeutic, long-term greater than 30 days reports (product code LJS) death is recorded in 0.3% and malfunction in 81.1%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are fluid/blood leak (41.1%), component incompatible (13.8%) and break (7.7%). The patient problems coded most often are swelling/ edema, foreign body in patient and pain. 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

0918Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 3Apr 2022: 3May 2022: 3Jun 2022: 15Jul 2022: 8Aug 2022: 3Sep 2022: 8Oct 2022: 3Nov 2022: 2Dec 2022: 22023Jan 2023: 3Feb 2023: 0Mar 2023: 0Apr 2023: 6May 2023: 0Jun 2023: 9Jul 2023: 6Aug 2023: 7Sep 2023: 9Oct 2023: 11Nov 2023: 11Dec 2023: 32024Jan 2024: 10Feb 2024: 18Mar 2024: 11Apr 2024: 7May 2024: 14Jun 2024: 16Jul 2024: 9Aug 2024: 8Sep 2024: 5Oct 2024: 6Nov 2024: 9Dec 2024: 52025Jan 2025: 5Feb 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

0591182020: 820202022: 5020222023: 6520232024: 11820242025: 52025

Event type and report source

Event type, as classified on the report

Death0%0
Injury8.9%22
Malfunction91.1%224
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%246
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 37,016 reports carrying product code LJS. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Fluid/blood leak10141.1%30.1%
Component incompatible3413.8%1.8%
Breakthe device broke197.7%11.5%
Failure to infuse135.3%1.5%
Material deformation114.5%6.9%
Corrodedthe device corroded93.7%0.1%
Defective component72.8%3%
Detachment of device or device componentpart of the device came off72.8%1.7%
Backflow62.4%0.6%
Contamination /decontamination problem52%1.4%
Material frayed52%2.5%
Tear, rip or hole in device packaging52%0.2%
Device dislodged or dislocated41.6%1.2%
Device markings/labelling problema problem with the device markings or label31.2%0.4%
Material twisted/bent31.2%1.1%
Suction problem31.2%0.3%
Difficult to insertthe device was hard to insert20.8%0.6%
Misassembled20.8%0.2%
Activation problem10.4%0.4%
Crackthe device cracked10.4%3.4%

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
Swelling/ edema114.5%
Foreign body in patientpart of a device left in the patient104.1%
Painpain, site not specified93.7%
Thrombosis/thrombus62.4%
Extravasation52%
Erythemaskin redness31.2%
Inflammationinflammation20.8%
Anxietyanxiety10.4%
Exposure to body fluids10.4%
Rashskin rash10.4%

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

In context

MeasureGroshong Nxt Clearvue 4f Single-Lumen Basic TrayProduct code LJSAll MAUDE reports
Reports24637,01626,136,888
Share of that pool—0.7%0%
Classified as death, per 1,000 reports039
Classified as injury8.9%16.8%36.2%
Classified as malfunction91.1%81.1%62.3%
Filed by the manufacturer100%92.9%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 LJS

BrandReportsLatest 12 monthsClassified as death
PowerPICC8565770.1%
Groshong Nxt Clearvue 4f Single-Lumen Basic Tray With Safety Introducer77400.1%
Bard PICC733840%
PowerPICC SOLO2, 3CG6921370%
PowerPICC SOLO26804880%
Groshong Nxt Clearvue 4f Single-Lumen Picc Basic Tray With Microintroducer43900.5%
Groshong CLEARVUE4194150%
Groshong NXT ClearVue3961500%
Groshong Nxt Clearvue 4f Single-Lumen Picc Basic Tray37700.3%
Powerpicc 3cg341180%
Nutriline328600.6%
Premicath338543.6%
Powerpicc Solo Catheter With Sherlock 3cg Tps Stylet 4f Full Tray30900%
Powerpicc Solo Catheter With Sherlock 3cg Tip Positioning System Tps Stylet 4f26400%
Vaxcel Pasv Picc28600.7%

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 Groshong Nxt Clearvue 4f Single-Lumen Basic Tray reports

How many FDA reports name Groshong Nxt Clearvue 4f Single-Lumen Basic Tray?

246 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 (91.1%) and injury (8.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

fluid/blood leak (41.1%), component incompatible (13.8%), break (7.7%), failure to infuse (5.3%) and material deformation (4.5%). 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 Groshong Nxt Clearvue 4f Single-Lumen Basic Tray 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.