Reported Reactions

Devices › Set, administration, for peritoneal dialysis, disposable

Device brand name · Transfer set

Minicap Pd Transfer Set Easy-Lock With Twist Clamp: medical device reports filed with FDA

1,903 reports name it, 1997–2008. Manufacturer given most often on reports: Baxter Healthcare. Product code KDJ.

1,903
device reports naming the brand
0% of all MAUDE reports · about 66 a year
0
reports, 12 months to August 2026
0 in the 12 months before
94.5%
classified as malfunction
33% across the product code
0.1%
classified as death, as reported
1 reports · not verified by FDA

1,903 medical device reports received by FDA name the brand "Minicap Pd Transfer Set Easy-Lock With Twist Clamp" (transfer set); the manufacturer given most often on reports is Baxter Healthcare; received from October 1997 to November 2008. 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 (94.5%), injury (4.8%) and other (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 leak/splash (35.8%), replace (25.7%) and fluid/blood leak (23.8%). The patient problems coded most often are treatment with medication(s), peritonitis and therapy/non-surgical treatment, aborted/stopped. 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 Pd Transfer Set Easy-Lock With Twist Clamp was received in the five years to August 2026; the latest was received in November 2008.

By year received

03537051997: 1519971998: 1121999: 7919992000: 1052001: 11620012002: 2272003: 17220032004: 942005: 70520052006: 2402007: 920072008: 29

Event type and report source

Event type, as classified on the report

Death0.1%1
Injury4.8%92
Malfunction94.5%1,799
Other0.3%6
Not given0.3%5

Who filed the report

Manufacturer report100%1,903
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
Leak/splashthe device leaked68135.8%3%
Replace49025.7%1.2%
Fluid/blood leak45223.8%7.5%
Component(s), broken37519.7%1.1%
Breakthe device broke1216.4%2.1%
Material separation934.9%0.7%
Crackthe device cracked663.5%2.9%
Disconnection603.2%4.4%
Loose462.4%0.2%
Defective component351.8%0.1%
Device displays incorrect message261.4%0.7%
Lockout mechanism failure241.3%0%
Loose or intermittent connection231.2%1.3%
Detachment of device component221.2%0.8%
Malfunction221.2%0%
Close, difficult to201.1%0%
Other (for use when an appropriate device code cannot be identified)180.9%0.2%
Tears, rips, holes in device, device material170.9%0.1%
Device issuea problem with the device120.6%0%
Component falling70.4%0.3%

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
Treatment with medication(s)1759.2%
Peritonitis573%
Therapy/non-surgical treatment, aborted/stopped532.8%
Hospitalization required462.4%
Therapy/non-surgical treatment, additional321.7%
Other (for use when an appropriate patient code cannot be identified)120.6%
Abdominal painstomach or belly pain110.6%
Therapy/non-surgical treatment/delayed/prolonged90.5%
Improved patient condition60.3%
Fever50.3%
No patient involvement50.3%
Bacterial infectiona bacterial infection20.1%
Complaint, ill-defined20.1%
Discharge20.1%
Fungal infectiona fungal infection20.1%

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

In context

MeasureMinicap Pd Transfer Set Easy-Lock With Twist ClampProduct code KDJAll MAUDE reports
Reports1,90372,32826,136,888
Share of that pool—2.6%0%
Classified as death, per 1,000 reports1339
Classified as injury4.8%63.6%36.2%
Classified as malfunction94.5%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%
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 Extend Life Pd Transfset W/Twist Clamp60300.3%
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 Pd Transfer Set Easy-Lock With Twist Clamp reports

How many FDA reports name Minicap Pd Transfer Set Easy-Lock With Twist Clamp?

1,903 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 (94.5%), injury (4.8%) and other (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

leak/splash (35.8%), replace (25.7%), fluid/blood leak (23.8%), component(s), broken (19.7%) and break (6.4%). 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 Pd Transfer Set Easy-Lock With 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.