Devices › Catheter, peritoneal, long-term indwelling
Device brand name · Catheter peritoneal long-term indwelling
Dialysis Unknown: medical device reports filed with FDA
402 reports name it, 2007–2025. Manufacturer given most often on reports: Covidien. Product code FJS.
- 402
- device reports naming the brand
- 0% of all MAUDE reports · about 21 a year
- 6
- reports, 12 months to August 2026
- 98 in the 12 months before
- 63.7%
- classified as malfunction
- 51.2% across the product code
- 5%
- classified as death, as reported
- 20 reports · not verified by FDA
402 medical device reports received by FDA name the brand "Dialysis Unknown" (catheter peritoneal long-term indwelling); the manufacturer given most often on reports is Covidien; received from May 2007 to October 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
6 reports arrived in the 12 months to August 2026, down 94% from 98 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 (63.7%), injury (29.6%) and death (5%); across all catheter, peritoneal, long-term indwelling reports (product code FJS) death is recorded in 1.9% and malfunction in 51.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (19.9%), product quality problem (11.9%) and migration (9.7%). The patient problems coded most often are bacterial infection, peritonitis and surgical procedure, additional. 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 2,381 reports carrying product code FJS. 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 |
|---|---|---|---|
| Breakthe device broke | 80 | 19.9% | 16.3% |
| Product quality problem | 48 | 11.9% | 3.4% |
| Migrationthe device moved from where it was placed | 39 | 9.7% | 4.6% |
| Insufficient flow or under infusion | 35 | 8.7% | 2% |
| Material puncture/hole | 18 | 4.5% | 2.1% |
| Infusion or flow problema problem with flow or infusion | 15 | 3.7% | 1.9% |
| Insufficient device problem information | 15 | 3.7% | 3.1% |
| Obstruction of flow | 13 | 3.2% | 3% |
| Migration or expulsion of device | 12 | 3% | 2.6% |
| Leak/splashthe device leaked | 6 | 1.5% | 7.6% |
| Detachment of device or device componentpart of the device came off | 5 | 1.2% | 2.1% |
| Material frayed | 5 | 1.2% | 0.2% |
| Crackthe device cracked | 4 | 1% | 2.3% |
| Defective component | 4 | 1% | 1.3% |
| Contamination | 3 | 0.7% | 0.5% |
| Difficult to removethe device was hard to remove | 3 | 0.7% | 0.6% |
| Fluid/blood leak | 3 | 0.7% | 4.4% |
| Material integrity problema problem with the device material | 3 | 0.7% | 0.9% |
| Adaptor, failure of | 2 | 0.5% | 0.3% |
| Cut in material | 2 | 0.5% | 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 |
|---|---|---|
| Bacterial infectiona bacterial infection | 18 | 4.5% |
| Peritonitis | 14 | 3.5% |
| Surgical procedure, additional | 13 | 3.2% |
| Thrombosis/thrombus | 9 | 2.2% |
| Unintended radiation exposure | 9 | 2.2% |
| Fever | 8 | 2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 7 | 1.7% |
| Deaththe patient died; cause not stated by this term | 7 | 1.7% |
| Hemorrhage/blood loss/bleeding | 7 | 1.7% |
| Thrombosis | 7 | 1.7% |
| Cardiac arrestthe heart stopped | 5 | 1.2% |
| Chillschills or shivering | 5 | 1.2% |
| Low blood pressure/ hypotension | 4 | 1% |
| Sepsisa severe body-wide response to infection | 4 | 1% |
| Bacteremia | 3 | 0.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Dialysis Unknown | Product code FJS | All MAUDE reports |
|---|---|---|---|
| Reports | 402 | 2,381 | 26,136,888 |
| Share of that pool | — | 16.9% | 0% |
| Classified as death, per 1,000 reports | 50 | 19 | 9 |
| Classified as injury | 29.6% | 40.9% | 36.2% |
| Classified as malfunction | 63.7% | 51.2% | 62.3% |
| Filed by the manufacturer | 100% | 63.7% | 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 FJS
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| PD Catheter | 392 | 161 | 2.3% |
| Argyle | 871 | 60 | 1% |
| Peritoneal Dialysis Catheter | 264 | 55 | 2.3% |
| Catheter | 244 | 9 | 3.7% |
| Kendall | 213 | 23 | 2.3% |
| Pleurx Pleural Catheter Mini Kit | 227 | 13 | 0.9% |
| Port-A-Cath | 196 | 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 Dialysis Unknown reports
How many FDA reports name Dialysis Unknown?
402 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 6 in the latest 12 months.
What kinds of events are reported?
malfunction (63.7%), injury (29.6%) and death (5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (19.9%), product quality problem (11.9%), migration (9.7%), insufficient flow or under infusion (8.7%) and material puncture/hole (4.5%). 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 Dialysis Unknown 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.