Reported Reactions

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

Device brand name · L-cath picc

L-Cath PICC S/L 26ga (1.9F) 0.60mm x 30cm: medical device reports filed with FDA

266 reports name it, 2020–2026. Manufacturer given most often on reports: Argon Medical Devices. Product code LJS.

266
device reports naming the brand
0% of all MAUDE reports · about 41 a year
33
reports, 12 months to August 2026
40 in the 12 months before
86.1%
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 266 reports that name the brand "L-Cath PICC S/L 26ga (1.9F) 0.60mm x 30cm" (l-cath picc), received between January 2020 and July 2026; the manufacturer given most often on reports is Argon Medical Devices. Spellings of one product vary from report to report.

33 reports arrived in the 12 months to August 2026, down 17% from 40 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 (86.1%) and injury (13.9%); 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 crack (39.8%), leak/splash (25.6%) and fluid/blood leak (23.3%). The patient problems coded most often are failure of implant, needle stick/puncture 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

01019Sep 2021: 1Oct 2021: 6Nov 2021: 5Dec 2021: 02022Jan 2022: 4Feb 2022: 3Mar 2022: 3Apr 2022: 1May 2022: 6Jun 2022: 2Jul 2022: 1Aug 2022: 1Sep 2022: 10Oct 2022: 2Nov 2022: 7Dec 2022: 102023Jan 2023: 13Feb 2023: 7Mar 2023: 2Apr 2023: 5May 2023: 5Jun 2023: 4Jul 2023: 0Aug 2023: 3Sep 2023: 2Oct 2023: 3Nov 2023: 2Dec 2023: 12024Jan 2024: 0Feb 2024: 4Mar 2024: 6Apr 2024: 4May 2024: 6Jun 2024: 3Jul 2024: 1Aug 2024: 4Sep 2024: 4Oct 2024: 1Nov 2024: 18Dec 2024: 32025Jan 2025: 1Feb 2025: 4Mar 2025: 0Apr 2025: 2May 2025: 0Jun 2025: 5Jul 2025: 1Aug 2025: 1Sep 2025: 0Oct 2025: 2Nov 2025: 19Dec 2025: 42026Jan 2026: 1Feb 2026: 2Mar 2026: 0Apr 2026: 0May 2026: 1Jun 2026: 3Jul 2026: 1Aug 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

027542020: 2920202021: 3920212022: 5020222023: 4720232024: 5420242025: 3920252026: 82026

Event type and report source

Event type, as classified on the report

Death0%0
Injury13.9%37
Malfunction86.1%229
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%266
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
Crackthe device cracked10639.8%3.4%
Leak/splashthe device leaked6825.6%6.2%
Fluid/blood leak6223.3%30.1%
Breakthe device broke3011.3%11.5%
Physical resistance/sticking72.6%0.6%
Difficult to removethe device was hard to remove62.3%1.8%
Material puncture/hole62.3%1.3%
Obstruction of flow51.9%1%
Blocked connection41.5%0%
Difficult to flush41.5%0.5%
Material deformation41.5%6.9%
Device slipped31.1%0.1%
Positioning problem31.1%0.3%
Detachment of device or device componentpart of the device came off20.8%1.7%
Disconnection20.8%0.3%
Entrapment of device20.8%0.4%
Flushing problem20.8%0.3%
Improper flow or infusion20.8%0.1%
Incomplete or inadequate connection20.8%0%
Insufficient device problem information20.8%1.1%

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
Failure of implant134.9%
Needle stick/puncture93.4%
Painpain, site not specified62.3%
Foreign body in patientpart of a device left in the patient41.5%
Hemorrhage/blood loss/bleeding41.5%
Appropriate clinical signs, symptoms and conditions term/code not available20.8%
Laceration(s)20.8%
Device embedded in tissue or plaque10.4%
Hyperglycemiahigh blood sugar10.4%
Hypoglycemialow blood sugar10.4%
Inflammationinflammation10.4%
No patient involvement10.4%
Pleural effusionfluid around the lung10.4%
Skin inflammation/ irritation10.4%
Swelling/ edema10.4%

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

In context

MeasureL-Cath PICC S/L 26ga (1.9F) 0.60mm x 30cmProduct code LJSAll MAUDE reports
Reports26637,01626,136,888
Share of that pool—0.7%0%
Classified as death, per 1,000 reports039
Classified as injury13.9%16.8%36.2%
Classified as malfunction86.1%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 L-Cath PICC S/L 26ga (1.9F) 0.60mm x 30cm reports

How many FDA reports name L-Cath PICC S/L 26ga (1.9F) 0.60mm x 30cm?

266 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 33 in the latest 12 months.

What kinds of events are reported?

malfunction (86.1%) and injury (13.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

crack (39.8%), leak/splash (25.6%), fluid/blood leak (23.3%), break (11.3%) and physical resistance/sticking (2.6%). 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 L-Cath PICC S/L 26ga (1.9F) 0.60mm x 30cm 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.