Devices › Port & catheter, implanted, subcutaneous, intravascular
Device brand name · Port & catheter implanted subcutaneous intravascular
PowerPort isp M.R.I. Implantable Port, ChronoFlex Single-Lumen, 8F: medical device reports filed with FDA
669 reports name it, 2020–2026. Manufacturer given most often on reports: C R Bard Basd -3006260740. Product code LJT.
- 669
- device reports naming the brand
- 0% of all MAUDE reports · about 112 a year
- 350
- reports, 12 months to August 2026
- 200 in the 12 months before
- 17.2%
- classified as malfunction
- 38.6% across the product code
- 4.6%
- classified as death, as reported
- 31 reports · not verified by FDA
669 medical device reports received by FDA name the brand "PowerPort isp M.R.I. Implantable Port, ChronoFlex Single-Lumen, 8F" (port & catheter implanted subcutaneous intravascular); 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.
350 reports arrived in the 12 months to August 2026, up 75% from 200 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 (78.2%), malfunction (17.2%) and death (4.6%); 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 (11.2%), device appears to trigger rejection (10.9%) and obstruction of flow (8.1%). The patient problems coded most often are thrombosis/thrombus, obstruction/occlusion and sepsis. 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 |
|---|---|---|---|
| Fracturea broken bone | 75 | 11.2% | 23.6% |
| Device appears to trigger rejection | 73 | 10.9% | 3% |
| Obstruction of flow | 54 | 8.1% | 3.7% |
| Migrationthe device moved from where it was placed | 39 | 5.8% | 5.6% |
| Expulsion | 26 | 3.9% | 1.2% |
| Suction problem | 24 | 3.6% | 4.5% |
| Difficult to flush | 16 | 2.4% | 3.5% |
| Material separation | 14 | 2.1% | 9% |
| Deformation due to compressive stress | 11 | 1.6% | 5.7% |
| Fluid/blood leak | 8 | 1.2% | 9.1% |
| Blocked connection | 6 | 0.9% | 0.6% |
| Material twisted/bent | 6 | 0.9% | 0.5% |
| Tear, rip or hole in device packaging | 5 | 0.7% | 0.4% |
| Detachment of device or device componentpart of the device came off | 4 | 0.6% | 2% |
| Device tipped over | 3 | 0.4% | 0.3% |
| Difficult to removethe device was hard to remove | 3 | 0.4% | 2.9% |
| Malposition of device | 3 | 0.4% | 0.3% |
| Material discolored | 3 | 0.4% | 0.2% |
| Packaging problem | 3 | 0.4% | 0.3% |
| Disconnection | 2 | 0.3% | 1.7% |
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 | 228 | 34.1% |
| Obstruction/occlusion | 35 | 5.2% |
| Sepsisa severe body-wide response to infection | 31 | 4.6% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 23 | 3.4% |
| Bacterial infectiona bacterial infection | 21 | 3.1% |
| Painpain, site not specified | 20 | 3% |
| Skin erosion | 20 | 3% |
| Bacteremia | 19 | 2.8% |
| Pulmonary embolisma blood clot in the lung | 16 | 2.4% |
| Swelling/ edema | 8 | 1.2% |
| Chest painchest pain | 6 | 0.9% |
| Erythemaskin redness | 6 | 0.9% |
| Hypersensitivity/allergic reaction | 6 | 0.9% |
| Embolism/embolus | 5 | 0.7% |
| Fungal infectiona fungal infection | 4 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | PowerPort isp M.R.I. Implantable Port, ChronoFlex Single-Lumen, 8F | Product code LJT | All MAUDE reports |
|---|---|---|---|
| Reports | 669 | 22,475 | 26,136,888 |
| Share of that pool | — | 3% | 0% |
| Classified as death, per 1,000 reports | 46 | 18 | 9 |
| Classified as injury | 78.2% | 57.7% | 36.2% |
| Classified as malfunction | 17.2% | 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% |
| 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 duo M.R.I. Implantable Port, ChronoFlex Dual-Lumen, 9.5F | 279 | 74 | 3.2% |
| 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 isp M.R.I. Implantable Port, ChronoFlex Single-Lumen, 8F reports
How many FDA reports name PowerPort isp M.R.I. Implantable Port, ChronoFlex Single-Lumen, 8F?
669 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 350 in the latest 12 months.
What kinds of events are reported?
injury (78.2%), malfunction (17.2%) and death (4.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fracture (11.2%), device appears to trigger rejection (10.9%), obstruction of flow (8.1%), migration (5.8%) and expulsion (3.9%). 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 isp M.R.I. Implantable Port, ChronoFlex Single-Lumen, 8F 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.