Reported Reactions

Devices › Port & catheter, implanted, subcutaneous, intravascular

Device brand name · Port & catheter implanted subcutaneous intravascular

Unknown Power Port: medical device reports filed with FDA

293 reports name it, 2021–2025. Manufacturer given most often on reports: C R Bard Basd -3006260740. Product code LJT.

293
device reports naming the brand
0% of all MAUDE reports · about 59 a year
5
reports, 12 months to August 2026
87 in the 12 months before
35.2%
classified as malfunction
38.6% across the product code
1.7%
classified as death, as reported
5 reports · not verified by FDA

FDA's MAUDE database holds 293 reports that name the brand "Unknown Power Port" (port & catheter implanted subcutaneous intravascular), received between July 2021 and October 2025; the manufacturer given most often on reports is C R Bard Basd -3006260740. Spellings of one product vary from report to report.

5 reports arrived in the 12 months to August 2026, down 94% from 87 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 injury (63.1%), malfunction (35.2%) and death (1.7%); across all port & catheter, implanted, subcutaneous, intravascular reports (product code LJT) death is recorded in 1.8% and malfunction in 38.6%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are fracture (12.3%), migration (7.5%) and difficult to flush (6.8%). The patient problems coded most often are thrombosis/thrombus, appropriate clinical signs, symptoms and conditions term/code not available and arrhythmia. 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

03365Sep 2021: 0Oct 2021: 0Nov 2021: 2Dec 2021: 22022Jan 2022: 0Feb 2022: 1Mar 2022: 2Apr 2022: 6May 2022: 1Jun 2022: 2Jul 2022: 2Aug 2022: 3Sep 2022: 7Oct 2022: 0Nov 2022: 3Dec 2022: 22023Jan 2023: 3Feb 2023: 5Mar 2023: 3Apr 2023: 2May 2023: 65Jun 2023: 3Jul 2023: 2Aug 2023: 10Sep 2023: 8Oct 2023: 5Nov 2023: 5Dec 2023: 122024Jan 2024: 7Feb 2024: 3Mar 2024: 5Apr 2024: 5May 2024: 5Jun 2024: 6Jul 2024: 7Aug 2024: 6Sep 2024: 4Oct 2024: 9Nov 2024: 12Dec 2024: 62025Jan 2025: 7Feb 2025: 7Mar 2025: 7Apr 2025: 6May 2025: 8Jun 2025: 8Jul 2025: 6Aug 2025: 7Sep 2025: 4Oct 2025: 1Nov 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

0621232021: 520212022: 2920222023: 12320232024: 7520242025: 612025

Event type and report source

Event type, as classified on the report

Death1.7%5
Injury63.1%185
Malfunction35.2%103
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%293
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 22,475 reports carrying product code LJT. 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 bone3612.3%23.6%
Migrationthe device moved from where it was placed227.5%5.6%
Difficult to flush206.8%3.5%
Obstruction of flow206.8%3.7%
Suction problem196.5%4.5%
Material separation186.1%9%
Fluid/blood leak175.8%9.1%
Expulsion103.4%1.2%
Blocked connection62%0.6%
Difficult to removethe device was hard to remove62%2.9%
Material protrusion/extrusion41.4%0.8%
Restricted flow rate41.4%0.3%
Deformation due to compressive stress31%5.7%
Device appears to trigger rejection31%3%
Material puncture/hole31%0.9%
Insufficient device problem information20.7%1%
Air/gas in device10.3%0.6%
Backflow10.3%0.1%
Breakthe device broke10.3%8.5%
Component misassembled10.3%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
Thrombosis/thrombus289.6%
Appropriate clinical signs, symptoms and conditions term/code not available248.2%
Arrhythmia227.5%
Painpain, site not specified134.4%
Sepsisa severe body-wide response to infection124.1%
Bacterial infectiona bacterial infection103.4%
Swelling/ edema103.4%
Skin erosion93.1%
Chest painchest pain82.7%
Bacteremia62%
Foreign body in patientpart of a device left in the patient62%
Embolism/embolus31%
Pneumothoraxa collapsed lung31%
Discomfortdiscomfort20.7%
Erythemaskin redness20.7%

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

In context

MeasureUnknown Power PortProduct code LJTAll MAUDE reports
Reports29322,47526,136,888
Share of that pool—1.3%0%
Classified as death, per 1,000 reports17189
Classified as injury63.1%57.7%36.2%
Classified as malfunction35.2%38.6%62.3%
Filed by the manufacturer100%83.8%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 LJT

BrandReportsLatest 12 monthsClassified as death
PowerPort ClearVUE isp Implantable Port, ChronoFlex Single-Lumen, 8F1,3276564.7%
PowerPort isp M.R.I. Implantable Port, Groshong Single-Lumen, 8F1,0432111.3%
PowerPort M.R.I. Implantable Port, ChronoFlex Single-Lumen, 8F6893414.2%
PowerPort isp M.R.I. Implantable Port, ChronoFlex Single-Lumen, 8F6693504.6%
Lifeport Vascular Access System60900.5%
PowerPort isp MRI 6F CHRONW/OS4561830%
Celsite452510.9%
Unknown Port435160.7%
Implanted Port4003684.3%
Smart Port CT3321924.2%
PowerPort ClearVUE Slim Implantable Port, ChronoFlex Single-Lumen, Kit, 8F2951645.4%
PowerPort duo M.R.I. Implantable Port, ChronoFlex Dual-Lumen, 9.5F279743.2%
PowerPort isp MRI 6CF Int w SP, ATT, SL2771400%
Power Port isp M.R.I., 8Fr Groshong225360%
M.R.I. Implantable Port, Hickman Single-Lumen, 9.6F213622.3%

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 Unknown Power Port reports

How many FDA reports name Unknown Power Port?

293 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 5 in the latest 12 months.

What kinds of events are reported?

injury (63.1%), malfunction (35.2%) and death (1.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

fracture (12.3%), migration (7.5%), difficult to flush (6.8%), obstruction of flow (6.8%) and suction problem (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 Unknown Power Port 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.