Reported Reactions

Devices › Set, administration, for peritoneal dialysis, disposable

Device brand name · Set administration for peritoneal dialysis disposable

Minicap Extend Life Pd Transfset W/Twist Clamp: medical device reports filed with FDA

603 reports name it, 2007–2011. Manufacturer given most often on reports: Baxter Healthcare - Mountain Home. Product code KDJ.

603
device reports naming the brand
0% of all MAUDE reports · about 31 a year
0
reports, 12 months to August 2026
0 in the 12 months before
72.3%
classified as malfunction
33% across the product code
0.3%
classified as death, as reported
2 reports · not verified by FDA

603 medical device reports received by FDA name the brand "Minicap Extend Life Pd Transfset W/Twist Clamp" (set administration for peritoneal dialysis disposable); the manufacturer given most often on reports is Baxter Healthcare - Mountain Home; received from April 2007 to November 2011. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

0 reports arrived in the 12 months to August 2026, and 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 malfunction (72.3%), injury (26%) and death (0.3%); 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 fluid/blood leak (21.7%), disconnection (16.9%) and break (13.1%). The patient problems coded most often are peritonitis, bacterial infection and treatment with medication(s). 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

No report naming Minicap Extend Life Pd Transfset W/Twist Clamp was received in the five years to August 2026; the latest was received in November 2011.

By year received

01593182007: 6420072008: 8720082009: 8220092010: 31820102011: 522011

Event type and report source

Event type, as classified on the report

Death0.3%2
Injury26%157
Malfunction72.3%436
Other0%0
Not given1.3%8

Who filed the report

Manufacturer report100%603
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)ReportsShareShare across product code
Fluid/blood leak13121.7%7.5%
Disconnection10216.9%4.4%
Breakthe device broke7913.1%2.1%
Detachment of device component559.1%0.8%
Improper or incorrect procedure or method508.3%13.1%
Insufficient device problem information467.6%9.2%
Crackthe device cracked437.1%2.9%
Component(s), broken355.8%1.1%
Component falling305%0.3%
Device displays incorrect message294.8%0.7%
Material separation294.8%0.7%
Loose or intermittent connection244%1.3%
Leak/splashthe device leaked203.3%3%
Contamination162.7%4.8%
Device slipped162.7%0.2%
Connection problema connection problem132.2%1.5%
Hole in material111.8%0.3%
Defective devicethe device was defective101.7%0%
Loose101.7%0.2%
Replace101.7%1.2%

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)ReportsShare
Peritonitis15325.4%
Bacterial infectiona bacterial infection6911.4%
Treatment with medication(s)305%
Abdominal painstomach or belly pain254.1%
Hospitalization required122%
Staphylococcus aureus111.8%
Therapy/non-surgical treatment, additional101.7%
Therapy/non-surgical treatment, aborted/stopped91.5%
Fever61%
Deaththe patient died; cause not stated by this term50.8%
Nauseafeeling sick50.8%
Discomfortdiscomfort40.7%
Improved patient condition40.7%
Diarrhea30.5%
Fungal infectiona fungal infection30.5%

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

In context

MeasureMinicap Extend Life Pd Transfset W/Twist ClampProduct code KDJAll MAUDE reports
Reports60372,32826,136,888
Share of that pool—0.8%0%
Classified as death, per 1,000 reports3339
Classified as injury26%63.6%36.2%
Classified as malfunction72.3%33%62.3%
Filed by the manufacturer100%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

BrandReportsLatest 12 monthsClassified as death
Ni32,9391,5871.8%
MiniCap Transfer Set10,1611681.1%
MiniCap13,8064091.1%
Minicap Pd Transfer Set Easy-Lock With Twist Clamp1,90300.1%
Renal - Disposable1,47201.4%
Uv Flash Transfer Sets1,04900%
Extension Set1,623661.3%
Capd Solution Transfer Set Short For Uv-Flash90200%
Flexicap82901.9%
Capd Disconnect Y Set68501.6%
Minicap Disconnect Cap57100.2%
Safe Lock Apd Luer Lock Connector51100%
Locking Titanium Adapter49451%
Uv-Flash Solution Transfer Set Short - Japan37400%
Minicap Prep Kits44140%

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 Extend Life Pd Transfset W/Twist Clamp reports

How many FDA reports name Minicap Extend Life Pd Transfset W/Twist Clamp?

603 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (72.3%), injury (26%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

fluid/blood leak (21.7%), disconnection (16.9%), break (13.1%), detachment of device component (9.1%) and improper or incorrect procedure or method (8.3%). 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 Extend Life Pd Transfset W/Twist Clamp 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.