Device brand name · Intermittent catheter
Intermittent Rochester Catheters: medical device reports filed with FDA
159 reports name it, 2018–2025. Manufacturer given most often on reports: C R Bard Covington -1018233. Product code EZD.
- 159
- device reports naming the brand
- 0% of all MAUDE reports · about 19 a year
- 0
- reports, 12 months to August 2026
- 5 in the 12 months before
- 80.5%
- classified as malfunction
- 71.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
159 medical device reports received by FDA name the brand "Intermittent Rochester Catheters" (intermittent catheter); the manufacturer given most often on reports is C R Bard Covington -1018233; received from March 2018 to July 2025. 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, against 5 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 (80.5%) and injury (19.5%); across all catheter, straight reports (product code EZD) death is recorded in 0.1% and malfunction in 71.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are improper chemical reaction (16.4%), difficult to insert (9.4%) and patient-device incompatibility (8.2%). The patient problems coded most often are urinary tract infection, 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 4,236 reports carrying product code EZD. 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 |
|---|---|---|---|
| Improper chemical reaction | 26 | 16.4% | 9.2% |
| Difficult to insertthe device was hard to insert | 15 | 9.4% | 6.9% |
| Patient-device incompatibilitythe device did not suit the patient | 13 | 8.2% | 3.8% |
| Product quality problem | 11 | 6.9% | 12% |
| Inaccurate flow rate | 10 | 6.3% | 1.6% |
| Material twisted/bent | 10 | 6.3% | 3% |
| Biocompatibility | 9 | 5.7% | 3.6% |
| Incorrect measurementthe device measured wrongly | 7 | 4.4% | 3.7% |
| Nonstandard device | 7 | 4.4% | 1.3% |
| Component missing | 5 | 3.1% | 2.1% |
| Device damaged prior to usethe device was damaged before use | 5 | 3.1% | 1.6% |
| Material integrity problema problem with the device material | 5 | 3.1% | 3.5% |
| Component misassembled | 4 | 2.5% | 2.9% |
| Fluid/blood leak | 4 | 2.5% | 0.5% |
| Scratched material | 4 | 2.5% | 0.7% |
| Sharp edges | 4 | 2.5% | 5.8% |
| Difficult to removethe device was hard to remove | 3 | 1.9% | 4.2% |
| Inadequacy of device shape and/or size | 3 | 1.9% | 1.6% |
| Incomplete or missing packaging | 3 | 1.9% | 0.1% |
| Material protrusion/extrusion | 3 | 1.9% | 0.6% |
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 |
|---|---|---|
| Urinary tract infectionbladder or urinary infection | 16 | 10.1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 15 | 9.4% |
| Painpain, site not specified | 10 | 6.3% |
| Discomfortdiscomfort | 8 | 5% |
| No patient involvement | 6 | 3.8% |
| Hemorrhage/blood loss/bleeding | 5 | 3.1% |
| Sepsisa severe body-wide response to infection | 3 | 1.9% |
| Blood loss | 2 | 1.3% |
| Laceration(s) | 2 | 1.3% |
| Tissue breakdown | 2 | 1.3% |
| Tissue damage | 2 | 1.3% |
| Bacterial infectiona bacterial infection | 1 | 0.6% |
| Burning sensationa burning feeling | 1 | 0.6% |
| Cyst(s) | 1 | 0.6% |
| Inflammationinflammation | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Intermittent Rochester Catheters | Product code EZD | All MAUDE reports |
|---|---|---|---|
| Reports | 159 | 4,236 | 26,136,888 |
| Share of that pool | — | 3.8% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 19.5% | 28.1% | 36.2% |
| Classified as malfunction | 80.5% | 71.6% | 62.3% |
| Filed by the manufacturer | 100% | 99.3% | 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 EZD
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Magic3 Go Intermittent Urinary Catheter | 830 | 9 | 0% |
| L3c0600 - Cure Products | 881 | 0 | 0% |
| Cure Products | 644 | 1 | 0% |
| Magic3 Go Male Catheter with SureGrip | 470 | 12 | 0% |
| Magic3 Go Male Coude Catheter with SureGrip | 439 | 36 | 0.2% |
| Cure Catheter | 216 | 107 | 0% |
| Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve | 1,505 | 71 | 0.1% |
| Gentlecath | 402 | 399 | 0% |
| Magic3 Intermittent Catheter | 530 | 11 | 0% |
| Magic3 Intermittent Catheter with Sure-Grip Sleeve | 1,400 | 22 | 0% |
| Bardex I.C. Foley Catheter | 4,010 | 562 | 0% |
| Bardex Lubricath Foley Catheter | 4,923 | 653 | 0% |
| Catheter | 244 | 9 | 3.7% |
| Gentlecath Air | 171 | 136 | 0% |
| Gentlecath Other | 307 | 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 Intermittent Rochester Catheters reports
How many FDA reports name Intermittent Rochester Catheters?
159 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 (80.5%) and injury (19.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
improper chemical reaction (16.4%), difficult to insert (9.4%), patient-device incompatibility (8.2%), product quality problem (6.9%) and inaccurate flow rate (6.3%). 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 Intermittent Rochester Catheters 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.