Devices › Catheter, peritoneal, long-term indwelling
Device brand name · Catheter peritoneal long-term indwelling
PD Catheter: medical device reports filed with FDA
392 reports name it, 2023–2026. Manufacturer given most often on reports: Covidien. Product code FJS.
- 392
- device reports naming the brand
- 0% of all MAUDE reports · about 131 a year
- 161
- reports, 12 months to August 2026
- 0 in the 12 months before
- 20.2%
- classified as malfunction
- 51.2% across the product code
- 2.3%
- classified as death, as reported
- 9 reports · not verified by FDA
392 medical device reports received by FDA name the brand "PD Catheter" (catheter peritoneal long-term indwelling); the manufacturer given most often on reports is Covidien; received from July 2023 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
161 reports arrived in the 12 months to August 2026, with 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 injury (71.4%), malfunction (20.2%) and other (6.1%); 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 malposition of device (9.7%), obstruction of flow (6.6%) and improper or incorrect procedure or method (5.6%). The patient problems coded most often are peritonitis, abdominal pain and appropriate clinical signs, symptoms and conditions term/code not available. 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 |
|---|---|---|---|
| Malposition of device | 38 | 9.7% | 2.7% |
| Obstruction of flow | 26 | 6.6% | 3% |
| Improper or incorrect procedure or method | 22 | 5.6% | 1.9% |
| Improper flow or infusion | 14 | 3.6% | 0.8% |
| Infusion or flow problema problem with flow or infusion | 13 | 3.3% | 1.9% |
| Insufficient device problem information | 11 | 2.8% | 3.1% |
| Fluid/blood leak | 10 | 2.6% | 4.4% |
| Migration or expulsion of device | 10 | 2.6% | 2.6% |
| Output problem | 9 | 2.3% | 0.7% |
| Patient device interaction problem | 9 | 2.3% | 0.8% |
| Microbial contamination of device | 8 | 2% | 0.5% |
| Positioning problem | 8 | 2% | 1% |
| Defective devicethe device was defective | 6 | 1.5% | 0.5% |
| Insufficient flow or under infusion | 6 | 1.5% | 2% |
| Material puncture/hole | 6 | 1.5% | 2.1% |
| Material twisted/bent | 6 | 1.5% | 0.4% |
| Migrationthe device moved from where it was placed | 6 | 1.5% | 4.6% |
| Patient-device incompatibilitythe device did not suit the patient | 6 | 1.5% | 0.2% |
| Breakthe device broke | 5 | 1.3% | 16.3% |
| Material split, cut or torn | 5 | 1.3% | 0.4% |
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 |
|---|---|---|
| Peritonitis | 102 | 26% |
| Abdominal painstomach or belly pain | 67 | 17.1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 32 | 8.2% |
| Failure of implant | 26 | 6.6% |
| Painpain, site not specified | 24 | 6.1% |
| Bacterial infectiona bacterial infection | 18 | 4.6% |
| Fungal infectiona fungal infection | 13 | 3.3% |
| Hypervolemia | 12 | 3.1% |
| Medical device site infectioninfection at the device site | 9 | 2.3% |
| Swelling/ edema | 9 | 2.3% |
| Erythemaskin redness | 8 | 2% |
| Dyspneashortness of breath | 7 | 1.8% |
| Adhesion(s) | 6 | 1.5% |
| Constipationconstipation | 6 | 1.5% |
| Device embedded in tissue or plaque | 6 | 1.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | PD Catheter | Product code FJS | All MAUDE reports |
|---|---|---|---|
| Reports | 392 | 2,381 | 26,136,888 |
| Share of that pool | — | 16.5% | 0% |
| Classified as death, per 1,000 reports | 23 | 19 | 9 |
| Classified as injury | 71.4% | 40.9% | 36.2% |
| Classified as malfunction | 20.2% | 51.2% | 62.3% |
| Filed by the manufacturer | 0% | 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 |
|---|---|---|---|
| Argyle | 871 | 60 | 1% |
| Dialysis Unknown | 402 | 6 | 5% |
| 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 PD Catheter reports
How many FDA reports name PD Catheter?
392 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 161 in the latest 12 months.
What kinds of events are reported?
injury (71.4%), malfunction (20.2%) and other (6.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
malposition of device (9.7%), obstruction of flow (6.6%), improper or incorrect procedure or method (5.6%), improper flow or infusion (3.6%) and infusion or flow problem (3.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
voluntary reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that PD Catheter 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.