Devices › Set, administration, for peritoneal dialysis, disposable
Device brand name · Set administration for peritoneal dialysis disposable
Flexicap: medical device reports filed with FDA
829 reports name it, 2011–2024. Manufacturer given most often on reports: Baxter Healthcare - Swinford. Product code KDJ.
- 829
- device reports naming the brand
- 0% of all MAUDE reports · about 54 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 10.9%
- classified as malfunction
- 33% across the product code
- 1.9%
- classified as death, as reported
- 16 reports · not verified by FDA
FDA's MAUDE database holds 829 reports that name the brand "Flexicap" (set administration for peritoneal dialysis disposable), received between February 2011 and August 2024; the manufacturer given most often on reports is Baxter Healthcare - Swinford. 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 injury (87.2%), malfunction (10.9%) and death (1.9%); 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 insufficient device problem information (38.1%), improper or incorrect procedure or method (15.6%) and contamination (14.2%). The patient problems coded most often are peritonitis, bacterial infection and abdominal pain. 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.
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 |
|---|---|---|---|
| Insufficient device problem information | 316 | 38.1% | 9.2% |
| Improper or incorrect procedure or method | 129 | 15.6% | 13.1% |
| Contamination | 118 | 14.2% | 4.8% |
| Device operates differently than expectedthe device behaved unexpectedly | 11 | 1.3% | 0.6% |
| Product quality problem | 11 | 1.3% | 1% |
| Device displays incorrect message | 7 | 0.8% | 0.7% |
| Tear, rip or hole in device packaging | 7 | 0.8% | 0.2% |
| Delivered as unsterile product | 4 | 0.5% | 0.1% |
| Device alarm system | 4 | 0.5% | 0.1% |
| Human-device interface problem | 4 | 0.5% | 0% |
| Unsealed device packaging | 4 | 0.5% | 0.4% |
| Contamination of device ingredient or reagent | 3 | 0.4% | 0.1% |
| Loose or intermittent connection | 3 | 0.4% | 1.3% |
| Device expiration issue | 2 | 0.2% | 0% |
| Air leak | 1 | 0.1% | 0.2% |
| Breakthe device broke | 1 | 0.1% | 2.1% |
| Connection problema connection problem | 1 | 0.1% | 1.5% |
| Detachment of device component | 1 | 0.1% | 0.8% |
| Device damaged prior to receipt by user | 1 | 0.1% | 0% |
| Infusion or flow problema problem with flow or infusion | 1 | 0.1% | 0% |
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 | 736 | 88.8% |
| Bacterial infectiona bacterial infection | 160 | 19.3% |
| Abdominal painstomach or belly pain | 83 | 10% |
| Staphylococcus aureus | 24 | 2.9% |
| Vomitingbeing sick | 18 | 2.2% |
| Deaththe patient died; cause not stated by this term | 17 | 2.1% |
| Fungal infectiona fungal infection | 14 | 1.7% |
| Diarrhea | 13 | 1.6% |
| Fever | 9 | 1.1% |
| Nauseafeeling sick | 9 | 1.1% |
| Sepsisa severe body-wide response to infection | 9 | 1.1% |
| Painpain, site not specified | 8 | 1% |
| Test result | 7 | 0.8% |
| Constipationconstipation | 5 | 0.6% |
| Dyspneashortness of breath | 5 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Flexicap | Product code KDJ | All MAUDE reports |
|---|---|---|---|
| Reports | 829 | 72,328 | 26,136,888 |
| Share of that pool | — | 1.1% | 0% |
| Classified as death, per 1,000 reports | 19 | 33 | 9 |
| Classified as injury | 87.2% | 63.6% | 36.2% |
| Classified as malfunction | 10.9% | 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% |
| 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% |
| Minicap Prep Kits | 441 | 4 | 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 Flexicap reports
How many FDA reports name Flexicap?
829 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?
injury (87.2%), malfunction (10.9%) and death (1.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (38.1%), improper or incorrect procedure or method (15.6%), contamination (14.2%), device operates differently than expected (1.3%) and product quality problem (1.3%). 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 Flexicap 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.