Devices › Catheter, intravascular, therapeutic, long-term greater than 30 days
Device brand name · Catheter intravascular therapeutic long-term greater than 30 days
Powerpicc Solo Catheter With Sherlock 3cg Tip Positioning System Tps Stylet 4f: medical device reports filed with FDA
264 reports name it, 2016–2023. Manufacturer given most often on reports: Bard Access Systems. Product code LJS.
- 264
- device reports naming the brand
- 0% of all MAUDE reports · about 25 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 90.5%
- classified as malfunction
- 81.1% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
264 medical device reports received by FDA name the brand "Powerpicc Solo Catheter With Sherlock 3cg Tip Positioning System Tps Stylet 4f" (catheter intravascular therapeutic long-term greater than 30 days); the manufacturer given most often on reports is Bard Access Systems; received from January 2016 to December 2023. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none 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 (90.5%) and injury (9.5%); 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 fluid/blood leak (40.2%), leak/splash (10.6%) and material puncture/hole (8.3%). The patient problems coded most often are pain, swelling and foreign body in patient. 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 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) | Reports | Share | Share across product code |
|---|---|---|---|
| Fluid/blood leak | 106 | 40.2% | 30.1% |
| Leak/splashthe device leaked | 28 | 10.6% | 6.2% |
| Material puncture/hole | 22 | 8.3% | 1.3% |
| Fracturea broken bone | 21 | 8% | 4.7% |
| Material deformation | 17 | 6.4% | 6.9% |
| Breakthe device broke | 15 | 5.7% | 11.5% |
| Backflow | 11 | 4.2% | 0.6% |
| Material frayed | 10 | 3.8% | 2.5% |
| Defective component | 5 | 1.9% | 3% |
| Failure to infuse | 5 | 1.9% | 1.5% |
| Deformation due to compressive stress | 4 | 1.5% | 0.8% |
| Material perforation | 4 | 1.5% | 0.1% |
| Hole in material | 3 | 1.1% | 1.9% |
| Malposition of device | 2 | 0.8% | 0.5% |
| Material twisted/bent | 2 | 0.8% | 1.1% |
| Obstruction of flow | 2 | 0.8% | 1% |
| Physical resistance/sticking | 2 | 0.8% | 0.6% |
| Unable to obtain readings | 2 | 0.8% | 0.2% |
| Air leak | 1 | 0.4% | 0.2% |
| Aspiration issue | 1 | 0.4% | 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) | Reports | Share |
|---|---|---|
| Painpain, site not specified | 7 | 2.7% |
| Swellingswelling | 7 | 2.7% |
| Foreign body in patientpart of a device left in the patient | 5 | 1.9% |
| Infiltration into tissue | 5 | 1.9% |
| Thrombus | 5 | 1.9% |
| Extravasation | 3 | 1.1% |
| Sepsisa severe body-wide response to infection | 3 | 1.1% |
| Erythemaskin redness | 2 | 0.8% |
| No patient involvement | 2 | 0.8% |
| Thrombosis | 2 | 0.8% |
| Bacterial infectiona bacterial infection | 1 | 0.4% |
| Blood loss | 1 | 0.4% |
| Discomfortdiscomfort | 1 | 0.4% |
| Exposure to body fluids | 1 | 0.4% |
| Hemorrhage/blood loss/bleeding | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Powerpicc Solo Catheter With Sherlock 3cg Tip Positioning System Tps Stylet 4f | Product code LJS | All MAUDE reports |
|---|---|---|---|
| Reports | 264 | 37,016 | 26,136,888 |
| Share of that pool | — | 0.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 9.5% | 16.8% | 36.2% |
| Classified as malfunction | 90.5% | 81.1% | 62.3% |
| Filed by the manufacturer | 100% | 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
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| PowerPICC | 856 | 577 | 0.1% |
| Groshong Nxt Clearvue 4f Single-Lumen Basic Tray With Safety Introducer | 774 | 0 | 0.1% |
| Bard PICC | 733 | 84 | 0% |
| PowerPICC SOLO2, 3CG | 692 | 137 | 0% |
| PowerPICC SOLO2 | 680 | 488 | 0% |
| Groshong Nxt Clearvue 4f Single-Lumen Picc Basic Tray With Microintroducer | 439 | 0 | 0.5% |
| Groshong CLEARVUE | 419 | 415 | 0% |
| Groshong NXT ClearVue | 396 | 150 | 0% |
| Groshong Nxt Clearvue 4f Single-Lumen Picc Basic Tray | 377 | 0 | 0.3% |
| Powerpicc 3cg | 341 | 18 | 0% |
| Nutriline | 328 | 60 | 0.6% |
| Premicath | 338 | 54 | 3.6% |
| Powerpicc Solo Catheter With Sherlock 3cg Tps Stylet 4f Full Tray | 309 | 0 | 0% |
| Vaxcel Pasv Picc | 286 | 0 | 0.7% |
| Morpheus Picc | 281 | 0 | 0% |
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 Powerpicc Solo Catheter With Sherlock 3cg Tip Positioning System Tps Stylet 4f reports
How many FDA reports name Powerpicc Solo Catheter With Sherlock 3cg Tip Positioning System Tps Stylet 4f?
264 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (90.5%) and injury (9.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fluid/blood leak (40.2%), leak/splash (10.6%), material puncture/hole (8.3%), fracture (8%) and material deformation (6.4%). 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 Powerpicc Solo Catheter With Sherlock 3cg Tip Positioning System Tps Stylet 4f 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.