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FDA product code MJC · class 2 · Gastroenterology, Urology
Catheter, urological (antimicrobial) and accessories: medical device reports filed with FDA
16,445 reports carry this product code, 1996–2026; 24 brands with a page.
- 16,445
- reports with this product code
- 0.1% of all MAUDE reports
- 2,503
- reports, 12 months to August 2026
- 3,350 in the 12 months before
- 96%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0.9% across all reports
Product code MJC is FDA's classification for "Catheter, urological (antimicrobial) and accessories" (gastroenterology, Urology panel), a class 2 device. 16,445 medical device reports carry this product code, 0.1% of the MAUDE database, from November 1996 to August 2026.
2,503 reports arrived in the 12 months to August 2026, down 25% from 3,350 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 (96%) and injury (3.9%). 24 brand names with a page on this site carry this code; the brands table is 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."
Brands with this product code
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."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| C R Bard Covington -1018233 | 15,914 | 96.8% |
| C R Bard | 262 | 1.6% |
| Productos Para El Cuidado De La Salud -9611590 | 153 | 0.9% |
| Bard | 6 | 0% |
| Medivance 1725056 | 3 | 0% |
| Unomedical Sdn Bhd | 1 | 0% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type and report source
Event type
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Material puncture/hole | 3,652 | 22.2% |
| Fluid/blood leak | 2,153 | 13.1% |
| Deflation problem | 2,147 | 13.1% |
| Difficult to removethe device was hard to remove | 1,403 | 8.5% |
| Decrease in pressure | 1,269 | 7.7% |
| Failure to infuse | 1,170 | 7.1% |
| Material rupture | 970 | 5.9% |
| Burst container or vessel | 819 | 5% |
| Inflation problem | 806 | 4.9% |
| Material split, cut or torn | 560 | 3.4% |
| Material fragmentation | 423 | 2.6% |
| Inaccurate flow rate | 417 | 2.5% |
| Component misassembled | 395 | 2.4% |
| Breakthe device broke | 364 | 2.2% |
| Leak/splashthe device leaked | 338 | 2.1% |
| Component missing | 269 | 1.6% |
| Device contamination with chemical or other material | 269 | 1.6% |
| Material twisted/bent | 249 | 1.5% |
| Short fill | 221 | 1.3% |
| Disconnection | 204 | 1.2% |
Questions about catheter, urological (antimicrobial) and accessories reports
What is product code MJC?
FDA's classification code for "Catheter, urological (antimicrobial) and accessories", class 2, reviewed by the gastroenterology, Urology panel. Every device report carries the product code of the device involved.
How many reports carry this code?
16,445 reports through August 2026, 2,503 of them in the latest 12 months.
Which brands appear most often?
Bardex Lubri-Sil I.C. Temperature-Sensing All-Silicone Foley Catheter (4,438), Bardex I.C. Foley Catheter (4,004), Bardex Lubri-Sil I.C. All-Silicone Foley Catheter (2,365), Bardex I.C. Temperature Sensing Foley Catheter (1,855) and Bardex I.C. Complete Care Foley Tray (1,018). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
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." Brands differ in how many are in use, how long they have been sold and how reports are collected.
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. 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.