Device brand name · Foley catheter
Bardex Lubricath Foley Catheter: medical device reports filed with FDA
4,923 reports name it, 2017–2026. Manufacturer given most often on reports: C R Bard Covington -1018233. Product code EZC.
- 4,923
- device reports naming the brand
- 0% of all MAUDE reports · about 528 a year
- 653
- reports, 12 months to August 2026
- 615 in the 12 months before
- 92.3%
- classified as malfunction
- 89.4% across the product code
- 0%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 4,923 reports that name the brand "Bardex Lubricath Foley Catheter" (foley catheter), received between March 2017 and August 2026; the manufacturer given most often on reports is C R Bard Covington -1018233. Spellings of one product vary from report to report.
653 reports arrived in the 12 months to August 2026, close to the 615 of 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 (92.3%) and injury (7.7%); across all catheter, coude reports (product code EZC) death is recorded in 0% and malfunction in 89.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are deflation problem (15.4%), material puncture/hole (12.6%) and burst container or vessel (10.5%). The patient problems coded most often are no patient involvement, appropriate clinical signs, symptoms and conditions term/code not available and 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 10,440 reports carrying product code EZC. 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 |
|---|---|---|---|
| Deflation problem | 759 | 15.4% | 12.5% |
| Material puncture/hole | 620 | 12.6% | 8.9% |
| Burst container or vessel | 517 | 10.5% | 9.4% |
| Fluid/blood leak | 509 | 10.3% | 9.5% |
| Difficult to removethe device was hard to remove | 465 | 9.4% | 8.8% |
| Material rupture | 434 | 8.8% | 7.3% |
| Decrease in pressure | 337 | 6.8% | 4.8% |
| Inflation problem | 306 | 6.2% | 4.7% |
| Failure to infuse | 282 | 5.7% | 4.5% |
| Breakthe device broke | 198 | 4% | 3.2% |
| Partial blockage | 167 | 3.4% | 3.8% |
| Material fragmentation | 159 | 3.2% | 2.9% |
| Inaccurate flow rate | 145 | 2.9% | 3.7% |
| Device fell | 119 | 2.4% | 1.5% |
| Device dislodged or dislocated | 112 | 2.3% | 2.4% |
| Material split, cut or torn | 112 | 2.3% | 1.8% |
| Leak/splashthe device leaked | 109 | 2.2% | 3% |
| Disconnection | 104 | 2.1% | 1.5% |
| Component falling | 61 | 1.2% | 1.2% |
| No flow | 61 | 1.2% | 1.4% |
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 |
|---|---|---|
| No patient involvement | 247 | 5% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 224 | 4.6% |
| Painpain, site not specified | 119 | 2.4% |
| Foreign body in patientpart of a device left in the patient | 112 | 2.3% |
| Hematuria | 64 | 1.3% |
| Urinary tract infectionbladder or urinary infection | 51 | 1% |
| Discomfortdiscomfort | 47 | 1% |
| Urinary retentionbeing unable to empty the bladder | 29 | 0.6% |
| Hemorrhage/blood loss/bleeding | 15 | 0.3% |
| Incontinence | 10 | 0.2% |
| Perforation | 9 | 0.2% |
| Device embedded in tissue or plaque | 8 | 0.2% |
| Fistula | 8 | 0.2% |
| Blood loss | 7 | 0.1% |
| Cancer | 6 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Bardex Lubricath Foley Catheter | Product code EZC | All MAUDE reports |
|---|---|---|---|
| Reports | 4,923 | 10,440 | 26,136,888 |
| Share of that pool | — | 47.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 7.7% | 10.6% | 36.2% |
| Classified as malfunction | 92.3% | 89.4% | 62.3% |
| Filed by the manufacturer | 99.7% | 98.4% | 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 EZC
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Bardia Foley Catheter Silicone Coated | 2,420 | 193 | 0% |
| Latex Foley Catheter | 1,368 | 7 | 0% |
| Unknown Latex Foley Catheter | 425 | 174 | 0% |
| Unknown Latex Temp-sensing Catheter | 320 | 54 | 0% |
| Bardex Lubricath Foley Catheter Coude Tip | 323 | 26 | 0% |
| Bard Lubricath Foley Catheter | 213 | 7 | 0% |
| Bardex Lubricath Foley Catheter Tiemann Model Coude | 179 | 19 | 0% |
| Bardex Lubricath Foley Catheter Creevy Model | 150 | 7 | 0% |
| Bardex Silicone Coated Foley Catheter | 186 | 36 | 0% |
| Foley Catheter | 262 | 2 | 0.8% |
| Bardex Lubri-Sil All-Silicone Foley Catheter | 1,412 | 294 | 0.1% |
| Bardex Foley Catheter Silicone Coated | 1,876 | 306 | 0.1% |
| Bardex I.C. Complete Care Foley Tray | 1,024 | 54 | 0% |
| Bardex I.C. Foley Catheter | 4,010 | 562 | 0% |
| Bard | 1,124 | 2 | 1.8% |
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 Bardex Lubricath Foley Catheter reports
How many FDA reports name Bardex Lubricath Foley Catheter?
4,923 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 653 in the latest 12 months.
What kinds of events are reported?
malfunction (92.3%) and injury (7.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
deflation problem (15.4%), material puncture/hole (12.6%), burst container or vessel (10.5%), fluid/blood leak (10.3%) and difficult to remove (9.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.7%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Bardex Lubricath Foley Catheter 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.