Reported Reactions

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

Device brand name · Chronic catheters

Hickman CV Catheter, Dual-Lumen, 7F: medical device reports filed with FDA

150 reports name it, 2020–2026. Manufacturer given most often on reports: C R Bard Basd -3006260740. Product code LJS.

150
device reports naming the brand
0% of all MAUDE reports · about 25 a year
39
reports, 12 months to August 2026
21 in the 12 months before
84.7%
classified as malfunction
81.1% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

150 medical device reports received by FDA name the brand "Hickman CV Catheter, Dual-Lumen, 7F" (chronic catheters); the manufacturer given most often on reports is C R Bard Basd -3006260740; received from July 2020 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

39 reports arrived in the 12 months to August 2026, up 86% 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 (84.7%) and injury (15.3%); 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 fracture (62.7%), fluid/blood leak (29.3%) and material separation (16%). The patient problems coded most often are appropriate clinical signs, symptoms and conditions term/code not available, extravasation 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

059Sep 2021: 1Oct 2021: 2Nov 2021: 0Dec 2021: 02022Jan 2022: 1Feb 2022: 2Mar 2022: 1Apr 2022: 3May 2022: 0Jun 2022: 1Jul 2022: 0Aug 2022: 3Sep 2022: 2Oct 2022: 1Nov 2022: 9Dec 2022: 32023Jan 2023: 2Feb 2023: 0Mar 2023: 0Apr 2023: 1May 2023: 0Jun 2023: 1Jul 2023: 0Aug 2023: 3Sep 2023: 1Oct 2023: 2Nov 2023: 3Dec 2023: 32024Jan 2024: 1Feb 2024: 0Mar 2024: 0Apr 2024: 0May 2024: 2Jun 2024: 0Jul 2024: 1Aug 2024: 7Sep 2024: 0Oct 2024: 2Nov 2024: 5Dec 2024: 12025Jan 2025: 1Feb 2025: 1Mar 2025: 2Apr 2025: 1May 2025: 4Jun 2025: 2Jul 2025: 1Aug 2025: 1Sep 2025: 5Oct 2025: 7Nov 2025: 1Dec 2025: 62026Jan 2026: 0Feb 2026: 1Mar 2026: 4Apr 2026: 0May 2026: 3Jun 2026: 3Jul 2026: 3Aug 2026: 6

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

016322020: 1020202021: 2720212022: 2620222023: 1620232024: 1920242025: 3220252026: 202026

Event type and report source

Event type, as classified on the report

Death0%0
Injury15.3%23
Malfunction84.7%127
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%150
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
Fracturea broken bone9462.7%4.7%
Fluid/blood leak4429.3%30.1%
Material separation2416%2.3%
Material puncture/hole1912.7%1.3%
Stretched1711.3%0.5%
Deformation due to compressive stress128%0.8%
Burst container or vessel96%0.6%
Material protrusion/extrusion96%0.3%
Suction problem74.7%0.3%
Detachment of device or device componentpart of the device came off53.3%1.7%
Material deformation53.3%6.9%
Material integrity problema problem with the device material53.3%0.4%
Difficult to flush42.7%0.5%
Failure to advance42.7%0.6%
Obstruction of flow42.7%1%
Improper or incorrect procedure or method32%0.6%
Air/gas in device21.3%0.1%
Contamination21.3%0.1%
Expulsion21.3%0.2%
Nonstandard device21.3%0.2%

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
Appropriate clinical signs, symptoms and conditions term/code not available64%
Extravasation64%
Painpain, site not specified42.7%
Unintended radiation exposure21.3%
Bacterial infectiona bacterial infection10.7%
Erythemaskin redness10.7%
Hemorrhage/blood loss/bleeding10.7%
Infiltration into tissue10.7%
Perforation of vessels10.7%
Sepsisa severe body-wide response to infection10.7%
Seromaa collection of fluid under the skin10.7%
Swelling/ edema10.7%
Thrombosis/thrombus10.7%

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

In context

MeasureHickman CV Catheter, Dual-Lumen, 7FProduct code LJSAll MAUDE reports
Reports15037,01626,136,888
Share of that pool—0.4%0%
Classified as death, per 1,000 reports039
Classified as injury15.3%16.8%36.2%
Classified as malfunction84.7%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 Hickman CV Catheter, Dual-Lumen, 7F reports

How many FDA reports name Hickman CV Catheter, Dual-Lumen, 7F?

150 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 39 in the latest 12 months.

What kinds of events are reported?

malfunction (84.7%) and injury (15.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

fracture (62.7%), fluid/blood leak (29.3%), material separation (16%), material puncture/hole (12.7%) and stretched (11.3%). 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 Hickman CV Catheter, Dual-Lumen, 7F 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.