Minicap Extended Life Pd Trns: medical device reports filed with FDA

216 reports name it, 2025–2026. Manufacturer given most often on reports: Vantive US Healthcare. Product code KDJ.

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.

216
device reports naming the brand: 0% of all MAUDE reports · about 145 a year; 85
reports, 12 months to August 2026: 131 in the 12 months before; 95.4%
classified as malfunction: 33% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

216 medical device reports received by FDA name the brand "Minicap Extended Life Pd Trns" (set administration for peritoneal dialysis disposable); the manufacturer given most often on reports is Vantive US Healthcare; received from January 2025 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

85 reports arrived in the 12 months to August 2026, down 35% from 131 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 (95.4%) and injury (4.6%); across all set, administration, for peritoneal dialysis, disposable reports (product code KDJ) death is recorded in 3.3% and malfunction in 33%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are detachment of device or device component (59.3%), failure to disconnect (13.4%) and difficult to open or close (9.3%). The patient problems coded most often are peritonitis. 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.

Event type and report source

Event type, as classified on the report

Death0%0

Injury4.6%10

Malfunction95.4%206

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%216

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 72,328 reports carrying product code KDJ. 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
Detachment of device or device componentpart of the device came off	128	59.3%	4.6%
Failure to disconnect	29	13.4%	0.7%
Difficult to open or close	20	9.3%	0.6%
Fluid/blood leak	19	8.8%	7.5%
Disconnection	12	5.6%	4.4%
Breakthe device broke	6	2.8%	2.1%
Free or unrestricted flow	4	1.9%	0.2%
Loose or intermittent connection	4	1.9%	1.3%
Improper or incorrect procedure or method	3	1.4%	13.1%
Crackthe device cracked	2	0.9%	2.9%
Device contamination with chemical or other material	2	0.9%	0.5%
Mechanical jam	2	0.9%	0%
Tear, rip or hole in device packaging	2	0.9%	0.2%
No flow	1	0.5%	0.1%

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	8	3.7%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Minicap Extended Life Pd Trns	Product code KDJ	All MAUDE reports
Reports	216	72,328	26,136,888
Share of that pool	—	0.3%	0%
Classified as death, per 1,000 reports	0	33	9
Classified as injury	4.6%	63.6%	36.2%
Classified as malfunction	95.4%	33%	62.3%
Filed by the manufacturer	100%	99.6%	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 KDJ

Brand	Reports	Latest 12 months	Classified as death
Ni	32,939	1,587	1.8%
MiniCap Transfer Set	10,161	168	1.1%
MiniCap	13,806	409	1.1%
Minicap Pd Transfer Set Easy-Lock With Twist Clamp	1,903	0	0.1%
Renal - Disposable	1,472	0	1.4%
Uv Flash Transfer Sets	1,049	0	0%
Extension Set	1,623	66	1.3%
Capd Solution Transfer Set Short For Uv-Flash	902	0	0%
Flexicap	829	0	1.9%
Capd Disconnect Y Set	685	0	1.6%
Minicap Extend Life Pd Transfset W/Twist Clamp	603	0	0.3%
Minicap Disconnect Cap	571	0	0.2%
Safe Lock Apd Luer Lock Connector	511	0	0%
Locking Titanium Adapter	494	5	1%
Uv-Flash Solution Transfer Set Short - Japan	374	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 Minicap Extended Life Pd Trns reports

How many FDA reports name Minicap Extended Life Pd Trns?

216 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 85 in the latest 12 months.

What kinds of events are reported?

malfunction (95.4%) and injury (4.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

detachment of device or device component (59.3%), failure to disconnect (13.4%), difficult to open or close (9.3%), fluid/blood leak (8.8%) and disconnection (5.6%). 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 Minicap Extended Life Pd Trns 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.