Devices › Port & catheter, implanted, subcutaneous, intravascular
Device brand name · Port & catheter implanted subcutaneous intravascular
PowerPort duo M.R.I. Implantable Port, ChronoFlex Dual-Lumen, 9.5F: medical device reports filed with FDA
279 reports name it, 2020–2026. Manufacturer given most often on reports: C R Bard Basd -3006260740. Product code LJT.
- 279
- device reports naming the brand
- 0% of all MAUDE reports · about 46 a year
- 74
- reports, 12 months to August 2026
- 45 in the 12 months before
- 43.4%
- classified as malfunction
- 38.6% across the product code
- 3.2%
- classified as death, as reported
- 9 reports · not verified by FDA
FDA's MAUDE database holds 279 reports that name the brand "PowerPort duo M.R.I. Implantable Port, ChronoFlex Dual-Lumen, 9.5F" (port & catheter implanted subcutaneous intravascular), received between June 2020 and August 2026; the manufacturer given most often on reports is C R Bard Basd -3006260740. Spellings of one product vary from report to report.
74 reports arrived in the 12 months to August 2026, up 64% from 45 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 (53.4%), malfunction (43.4%) and death (3.2%); 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 material protrusion/extrusion (25.4%), difficult to flush (20.1%) and fluid/blood leak (18.6%). The patient problems coded most often are thrombosis/thrombus, obstruction/occlusion and extravasation. 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 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) | Reports | Share | Share across product code |
|---|---|---|---|
| Material protrusion/extrusion | 71 | 25.4% | 0.8% |
| Difficult to flush | 56 | 20.1% | 3.5% |
| Fluid/blood leak | 52 | 18.6% | 9.1% |
| Obstruction of flow | 37 | 13.3% | 3.7% |
| Device appears to trigger rejection | 24 | 8.6% | 3% |
| Fracturea broken bone | 23 | 8.2% | 23.6% |
| Suction problem | 19 | 6.8% | 4.5% |
| Partial blockage | 14 | 5% | 0.2% |
| Material separation | 8 | 2.9% | 9% |
| Expulsion | 5 | 1.8% | 1.2% |
| Blocked connection | 4 | 1.4% | 0.6% |
| Failure to infuse | 4 | 1.4% | 0.7% |
| Migrationthe device moved from where it was placed | 4 | 1.4% | 5.6% |
| Device dislodged or dislocated | 3 | 1.1% | 0.4% |
| Connection problema connection problem | 2 | 0.7% | 0.2% |
| Difficult to removethe device was hard to remove | 2 | 0.7% | 2.9% |
| Loose or intermittent connection | 2 | 0.7% | 0.3% |
| Material split, cut or torn | 2 | 0.7% | 0.4% |
| Reflux within device | 2 | 0.7% | 0.2% |
| Restricted flow rate | 2 | 0.7% | 0.3% |
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 |
|---|---|---|
| Thrombosis/thrombus | 58 | 20.8% |
| Obstruction/occlusion | 24 | 8.6% |
| Extravasation | 21 | 7.5% |
| Painpain, site not specified | 14 | 5% |
| Swelling/ edema | 12 | 4.3% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 8 | 2.9% |
| Bacterial infectiona bacterial infection | 8 | 2.9% |
| Sepsisa severe body-wide response to infection | 6 | 2.2% |
| Skin erosion | 4 | 1.4% |
| Bacteremia | 3 | 1.1% |
| Bruise/contusion | 3 | 1.1% |
| Fungal infectiona fungal infection | 3 | 1.1% |
| Pulmonary embolisma blood clot in the lung | 3 | 1.1% |
| Cellulitisa skin infection | 2 | 0.7% |
| Discomfortdiscomfort | 2 | 0.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | PowerPort duo M.R.I. Implantable Port, ChronoFlex Dual-Lumen, 9.5F | Product code LJT | All MAUDE reports |
|---|---|---|---|
| Reports | 279 | 22,475 | 26,136,888 |
| Share of that pool | — | 1.2% | 0% |
| Classified as death, per 1,000 reports | 32 | 18 | 9 |
| Classified as injury | 53.4% | 57.7% | 36.2% |
| Classified as malfunction | 43.4% | 38.6% | 62.3% |
| Filed by the manufacturer | 100% | 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
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| PowerPort ClearVUE isp Implantable Port, ChronoFlex Single-Lumen, 8F | 1,327 | 656 | 4.7% |
| PowerPort isp M.R.I. Implantable Port, Groshong Single-Lumen, 8F | 1,043 | 211 | 1.3% |
| PowerPort M.R.I. Implantable Port, ChronoFlex Single-Lumen, 8F | 689 | 341 | 4.2% |
| PowerPort isp M.R.I. Implantable Port, ChronoFlex Single-Lumen, 8F | 669 | 350 | 4.6% |
| Lifeport Vascular Access System | 609 | 0 | 0.5% |
| PowerPort isp MRI 6F CHRONW/OS | 456 | 183 | 0% |
| Celsite | 452 | 51 | 0.9% |
| Unknown Port | 435 | 16 | 0.7% |
| Implanted Port | 400 | 368 | 4.3% |
| Smart Port CT | 332 | 192 | 4.2% |
| PowerPort ClearVUE Slim Implantable Port, ChronoFlex Single-Lumen, Kit, 8F | 295 | 164 | 5.4% |
| Unknown Power Port | 293 | 5 | 1.7% |
| PowerPort isp MRI 6CF Int w SP, ATT, SL | 277 | 140 | 0% |
| Power Port isp M.R.I., 8Fr Groshong | 225 | 36 | 0% |
| M.R.I. Implantable Port, Hickman Single-Lumen, 9.6F | 213 | 62 | 2.3% |
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 PowerPort duo M.R.I. Implantable Port, ChronoFlex Dual-Lumen, 9.5F reports
How many FDA reports name PowerPort duo M.R.I. Implantable Port, ChronoFlex Dual-Lumen, 9.5F?
279 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 74 in the latest 12 months.
What kinds of events are reported?
injury (53.4%), malfunction (43.4%) and death (3.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material protrusion/extrusion (25.4%), difficult to flush (20.1%), fluid/blood leak (18.6%), obstruction of flow (13.3%) and device appears to trigger rejection (8.6%). 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 PowerPort duo M.R.I. Implantable Port, ChronoFlex Dual-Lumen, 9.5F 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.