Set, administration, for peritoneal dialysis, disposable: medical device reports filed with FDA

72,328 reports carry this product code, 1994–2026; 30 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.

72,328
reports with this product code: 0.3% of all MAUDE reports; 1,937
reports, 12 months to August 2026: 3,000 in the 12 months before; 33%
classified as malfunction: 62.3% across all reports; 3.3%
classified as death, as reported: 0.9% across all reports

Product code KDJ is FDA's classification for "Set, administration, for peritoneal dialysis, disposable" (gastroenterology, Urology panel), a class 2 device. 72,328 medical device reports carry this product code, 0.3% of the MAUDE database, from March 1994 to August 2026.

1,937 reports arrived in the 12 months to August 2026, down 35% from 3,000 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 (63.6%), malfunction (33%) and death (3.3%). 30 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
Ni	20,553	1,587	1.8%	29.5%
MiniCap Transfer Set	10,114	168	1.1%	69.4%
MiniCap	4,646	409	1.1%	75%
Minicap Pd Transfer Set Easy-Lock With Twist Clamp	1,899	0	0.1%	94.5%
Renal - Disposable	1,227	0	1.4%	12.3%
Uv Flash Transfer Sets	1,030	0	0%	97.7%
Extension Set	909	66	1.3%	56.6%
Capd Solution Transfer Set Short For Uv-Flash	900	0	0%	97.7%
Flexicap	829	0	1.9%	10.9%
Capd Disconnect Y Set	682	0	1.6%	67%
Minicap Extend Life Pd Transfset W/Twist Clamp	596	0	0.3%	72.3%
Minicap Disconnect Cap	571	0	0.2%	82.3%
Safe Lock Apd Luer Lock Connector	504	0	0%	96.1%
Locking Titanium Adapter	492	5	1%	85.6%
Uv-Flash Solution Transfer Set Short - Japan	367	0	0%	94.1%
Minicap Prep Kits	339	4	0%	98.9%
Titanium Transfer Set	267	1	0%	93.6%
Connection Shield	265	0	0%	99.6%
Minicap Extended Life Pd Trns	216	85	0%	95.4%
12 Ft Extension Set Easy Lock Connector	214	0	0%	93.6%
Liberty Cycler Set Single Conn /Ext Dl	190	952	0.5%	68.1%
HomeChoice Automated PD Set with Cassette	82	149	0.5%	87%
Mini-Cap Disconnect W/Pvp-1solution	20	0	3.5%	12.1%
Integrated Apd Set W/Cassette3-Prong	17	0	0.4%	85.7%
Automated Pd Set W/Cassette4 Prong	13	0	0.3%	87%
Liberty Cycler Set Single Patient Conn	11	26	0.9%	65.8%
Homechoice	6	0	2.4%	95.8%
Peritoneal Dialysis Catheter	5	55	2.3%	29.2%
Fresenius Liberty Cycler	4	0	9.9%	11.5%
Homechoice Pro	4	0	3.6%	93.4%

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
Baxter Healthcare	47,763	66%
Baxter Healthcare - Mountain Home	11,205	15.5%
Baxter Healthcare - Swinford	3,183	4.4%
Vantive US Healthcare	3,075	4.3%
Baxter International	908	1.3%
Baxter Healthcare - Guangzhou	904	1.2%
Erika De Reynosa De C V	860	1.2%
Baxter Healthcare - Cleveland	560	0.8%
Baxter Healthcare - Cali	262	0.4%
Baxter Healthcare - Largo	236	0.3%
Reynosa Manufacturing	145	0.2%
Fresenius Medical Care North America	44	0.1%
Fresenius USA	40	0.1%
Baxter Healthcare - Singapore	32	0%
Baxter Healthcare - Malta	5	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

Death3.3%2,403

Injury63.6%45,970

Malfunction33%23,854

Other0.1%37

Not given0.1%64

Who filed

Manufacturer report99.6%72,074

Voluntary report0.2%148

User facility report0%0

Distributor report0.1%41

Not given0.1%65

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

Device problems coded

Device problem (FDA code)	Reports	Share
Improper or incorrect procedure or method	9,509	13.1%
Insufficient device problem information	6,655	9.2%
Fluid/blood leak	5,428	7.5%
Contamination	3,456	4.8%
Detachment of device or device componentpart of the device came off	3,318	4.6%
Disconnection	3,203	4.4%
Leak/splashthe device leaked	2,155	3%
Crackthe device cracked	2,087	2.9%
Breakthe device broke	1,484	2.1%
Connection problema connection problem	1,075	1.5%
Loose or intermittent connection	919	1.3%
Replace	859	1.2%
Component(s), broken	822	1.1%
Product quality problem	744	1%
Detachment of device component	585	0.8%
Material separation	533	0.7%
Failure to disconnect	490	0.7%
Device displays incorrect message	476	0.7%
Difficult to open or close	450	0.6%
Device operates differently than expectedthe device behaved unexpectedly	420	0.6%

Questions about set, administration, for peritoneal dialysis, disposable reports

What is product code KDJ?

FDA's classification code for "Set, administration, for peritoneal dialysis, disposable", 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?

72,328 reports through August 2026, 1,937 of them in the latest 12 months.

Which brands appear most often?

Ni (20,553), MiniCap Transfer Set (10,114), MiniCap (4,646), Minicap Pd Transfer Set Easy-Lock With Twist Clamp (1,899) and Renal - Disposable (1,227). 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.