Catheter, peritoneal, long-term indwelling: medical device reports filed with FDA

2,381 reports carry this product code, 1994–2026; 8 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

2,381
reports with this product code: 0% of all MAUDE reports; 252
reports, 12 months to August 2026: 159 in the 12 months before; 51.2%
classified as malfunction: 62.3% across all reports; 1.9%
classified as death, as reported: 0.9% across all reports

Product code FJS is FDA's classification for "Catheter, peritoneal, long-term indwelling" (gastroenterology, Urology panel), a class 2 device. 2,381 medical device reports carry this product code, 0% of the MAUDE database, from February 1994 to August 2026.

252 reports arrived in the 12 months to August 2026, up 58% from 159 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 (51.2%), injury (40.9%) and other (5.1%). 8 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
PD Catheter	376	161	2.3%	20.2%
Argyle	353	60	1%	82.4%
Dialysis Unknown	277	6	5%	63.7%
Peritoneal Dialysis Catheter	238	55	2.3%	29.2%
Catheter	27	9	3.7%	27.9%
Kendall	3	23	2.3%	61.5%
Pleurx Pleural Catheter Mini Kit	1	13	0.9%	75.8%
Port-A-Cath	1	0	0%	28.6%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Covidien Mfg Solutions	526	22.1%
Covidien	393	16.5%
Merit Medical Systems	92	3.9%
Horizon Medical Products	21	0.9%
Medcomp	7	0.3%
Bard Access Systems	6	0.3%
C R Bard Basd	1	0%
Covidien North Haven	1	0%
Davol	1	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death1.9%46

Injury40.9%973

Malfunction51.2%1,219

Other5.1%122

Not given0.9%21

Who filed

Manufacturer report63.7%1,517

Voluntary report33.8%804

User facility report0%0

Distributor report0%0

Not given2.5%60

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	389	16.3%
Hole in material	180	7.6%
Leak/splashthe device leaked	180	7.6%
Migrationthe device moved from where it was placed	109	4.6%
Fluid/blood leak	104	4.4%
Product quality problem	82	3.4%
Insufficient device problem information	74	3.1%
Obstruction of flow	71	3%
Explanted	66	2.8%
Malposition of device	64	2.7%
Migration or expulsion of device	63	2.6%
Replace	57	2.4%
Crackthe device cracked	55	2.3%
Detachment of device or device componentpart of the device came off	49	2.1%
Material puncture/hole	49	2.1%
Connection problema connection problem	48	2%
Insufficient flow or under infusion	48	2%
Infusion or flow problema problem with flow or infusion	46	1.9%
Improper or incorrect procedure or method	45	1.9%
Tears, rips, holes in device, device material	42	1.8%

Questions about catheter, peritoneal, long-term indwelling reports

What is product code FJS?

FDA's classification code for "Catheter, peritoneal, long-term indwelling", class 2, reviewed by the gastroenterology, Urology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

2,381 reports through August 2026, 252 of them in the latest 12 months.

Which brands appear most often?

PD Catheter (376), Argyle (353), Dialysis Unknown (277), Peritoneal Dialysis Catheter (238) and Catheter (27). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.