Devices › Set, administration, for peritoneal dialysis, disposable
Device brand name · Extension line
12 Ft Extension Set Easy Lock Connector: medical device reports filed with FDA
218 reports name it, 1998–2006. Manufacturer given most often on reports: Baxter Healthcare. Product code KDJ.
- 218
- device reports naming the brand
- 0% of all MAUDE reports · about 8 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 93.6%
- classified as malfunction
- 33% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 218 reports that name the brand "12 Ft Extension Set Easy Lock Connector" (extension line), received between January 1998 and November 2006; the manufacturer given most often on reports is Baxter Healthcare. Spellings of one product vary from report to report.
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 (93.6%), injury (4.1%) and other (2.3%); 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 replace (39.4%), device displays incorrect message (36.7%) and leak/splash (21.6%). The patient problems coded most often are therapy/non-surgical treatment, aborted/stopped, therapy/non-surgical treatment, additional 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 12 Ft Extension Set Easy Lock Connector was received in the five years to August 2026; the latest was received in November 2006.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
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 |
|---|---|---|---|
| Replace | 86 | 39.4% | 1.2% |
| Device displays incorrect message | 80 | 36.7% | 0.7% |
| Leak/splashthe device leaked | 47 | 21.6% | 3% |
| Alarm, audible | 17 | 7.8% | 0.1% |
| Failure to prime | 16 | 7.3% | 0% |
| Disconnection | 15 | 6.9% | 4.4% |
| Fluid/blood leak | 15 | 6.9% | 7.5% |
| Hole in material | 13 | 6% | 0.3% |
| Improper or incorrect procedure or method | 13 | 6% | 13.1% |
| Air leak | 11 | 5% | 0.2% |
| Material separation | 9 | 4.1% | 0.7% |
| Method, improper/incorrect | 8 | 3.7% | 0% |
| Other (for use when an appropriate device code cannot be identified) | 6 | 2.8% | 0.2% |
| Tears, rips, holes in device, device material | 5 | 2.3% | 0.1% |
| Bubble(s) | 3 | 1.4% | 0% |
| Device alarm system | 3 | 1.4% | 0.1% |
| Device issuea problem with the device | 3 | 1.4% | 0% |
| Loose or intermittent connection | 3 | 1.4% | 1.3% |
| Connection error | 2 | 0.9% | 0% |
| Contamination | 2 | 0.9% | 4.8% |
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 |
|---|---|---|
| Therapy/non-surgical treatment, aborted/stopped | 112 | 51.4% |
| Therapy/non-surgical treatment, additional | 20 | 9.2% |
| Treatment with medication(s) | 18 | 8.3% |
| Painpain, site not specified | 14 | 6.4% |
| Therapy/non-surgical treatment/delayed/prolonged | 7 | 3.2% |
| Other (for use when an appropriate patient code cannot be identified) | 6 | 2.8% |
| Peritonitis | 6 | 2.8% |
| Abdominal painstomach or belly pain | 4 | 1.8% |
| Air embolism | 2 | 0.9% |
| Chest painchest pain | 2 | 0.9% |
| Discomfortdiscomfort | 2 | 0.9% |
| Hospitalization required | 2 | 0.9% |
| Purulent discharge | 2 | 0.9% |
| Cramp(s) | 1 | 0.5% |
| Drainage | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | 12 Ft Extension Set Easy Lock Connector | Product code KDJ | All MAUDE reports |
|---|---|---|---|
| Reports | 218 | 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 | 4.1% | 63.6% | 36.2% |
| Classified as malfunction | 93.6% | 33% | 62.3% |
| Filed by the manufacturer | 99.5% | 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 12 Ft Extension Set Easy Lock Connector reports
How many FDA reports name 12 Ft Extension Set Easy Lock Connector?
218 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 (93.6%), injury (4.1%) and other (2.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
replace (39.4%), device displays incorrect message (36.7%), leak/splash (21.6%), alarm, audible (7.8%) and failure to prime (7.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that 12 Ft Extension Set Easy Lock Connector 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.