Device manufacturer, as written on reports
C R Bard Covington -1018233: medical device reports filed with FDA
60,777 reports name it as the manufacturer of the device involved, 2012–2026.
- 60,777
- reports naming it as manufacturer
- 0.2% of all MAUDE reports
- 8,290
- reports, 12 months to August 2026
- 7,949 in the 12 months before
- 85%
- classified as malfunction
- 62.3% across all reports
- 0.1%
- classified as death, as reported
- 0.9% across all reports
60,777 medical device reports received by FDA give C R Bard Covington -1018233 as the manufacturer of the device involved, 0.2% of the MAUDE database, from March 2012 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.
8,290 reports arrived in the 12 months to August 2026, close to the 7,949 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 (85%), injury (14.9%) and death (0.1%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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 named most often
| Brand | Device type | Reports | Latest 12 months | Classified as death |
|---|---|---|---|---|
| Bardex Lubricath Foley Catheter | Catheter, coude | 4,886 | 653 | 0% |
| Bardex Lubri-Sil I.C. Temperature-Sensing All-Silicone Foley Catheter | Catheter, urological (antimicrobial) and accessories | 4,422 | 871 | 0% |
| Bardex I.C. Foley Catheter | Catheter, urological (antimicrobial) and accessories | 3,998 | 562 | 0% |
| Bardex Lubri-Sil I.C. All-Silicone Foley Catheter | Catheter, urological (antimicrobial) and accessories | 3,111 | 620 | 0% |
| Bardia Foley Catheter Silicone Coated | Catheter, coude | 2,412 | 193 | 0% |
| Bardex Foley Catheter Silicone Coated | Catheter, urological | 1,858 | 306 | 0.1% |
| Bardex I.C. Temperature Sensing Foley Catheter | Catheter, urological (antimicrobial) and accessories | 1,845 | 303 | 0% |
| Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve | Catheter, urological | 1,490 | 71 | 0.1% |
| Bardex All-Silicone Foley Catheter | Catheter, retention type, balloon | 1,472 | 196 | 0% |
| PureWick Urine Collection System | Collector, urine, powered, non indwelling catheter | 1,462 | 1,129 | 0.1% |
| Magic3 Intermittent Catheter with Sure-Grip Sleeve | Catheter, urological | 1,389 | 22 | 0% |
| Bardex Lubri-Sil All-Silicone Foley Catheter | Catheter, retention type, balloon | 1,348 | 294 | 0.1% |
| Latex Foley Catheter | Catheter, coude | 1,247 | 7 | 0% |
| PureWick Female External Catheter | Collector, urine, powered, non indwelling catheter | 1,152 | 114 | 0.6% |
| Bardex I.C. Complete Care Foley Tray | Catheter, urological (antimicrobial) and accessories | 978 | 54 | 0% |
| Magic3 Go Intermittent Urinary Catheter | Catheter, straight | 789 | 9 | 0% |
| Bard DigniShield Stool Management System | Tubes, gastrointestinal (and accessories) | 649 | 94 | 0.7% |
| Personal Catheter Intermittent Catheter | Catheter, urological | 588 | 12 | 0% |
| Magic3 Go Male Catheter with SureGrip | Catheter, straight | 425 | 12 | 0% |
| Magic3 Go Male Coude Catheter with SureGrip | Catheter, straight | 412 | 36 | 0.2% |
| Magic3 Intermittent Catheter | Catheter, urological | 403 | 11 | 0% |
| Bardex Lubri-Sil I.C. All-Silicone Temp Sensing Foley Catheter | Catheter, urological (antimicrobial) and accessories | 383 | 57 | 0.2% |
| Sl Foley Swivel Silicone Tricot 25bx | Holder, ureteral catheter | 367 | 0 | 0% |
| Bard InLay Optima Ureteral Stent | Stent, ureteral | 354 | 44 | 0% |
| Unknown Latex Foley Catheter | Catheter, coude | 336 | 174 | 0% |
| Bardia Coude Olive Tip Urethral Foley Catheter | Catheter, urological | 299 | 15 | 0% |
| PureWick Flex Female External Catheter | Collector, urine, powered, non indwelling catheter | 267 | 220 | 0% |
| Unknown Latex Temp-sensing Catheter | Catheter, coude | 263 | 54 | 0% |
| Channel Drain | Catheter, irrigation | 228 | 66 | 0% |
| Closed Wound Suction | Apparatus, suction, single patient use, portable, nonpowered | 220 | 80 | 0% |
Brands with a page on this site, 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."
Device types
| Product code | Device type | Reports | Share |
|---|---|---|---|
| MJC | Catheter, urological (antimicrobial) and accessories | 15,914 | 26.2% |
| KOD | Catheter, urological | 10,071 | 16.6% |
| EZC | Catheter, coude | 9,811 | 16.1% |
| EZL | Catheter, retention type, balloon | 5,089 | 8.4% |
| NZU | Collector, urine, powered, non indwelling catheter | 3,872 | 6.4% |
| EZD | Catheter, straight | 2,229 | 3.7% |
| KNX | Collector, urine, (and accessories) for indwelling catheter | 1,593 | 2.6% |
| FAD | Stent, ureteral | 1,393 | 2.3% |
| EYJ | Holder, ureteral catheter | 953 | 1.6% |
| GCY | Apparatus, suction, single patient use, portable, nonpowered | 907 | 1.5% |
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
Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.
Questions about C R Bard Covington -1018233 reports
How many FDA device reports name C R Bard Covington -1018233 as manufacturer?
60,777 reports through August 2026, 8,290 of them in the latest 12 months.
Which of its brands appear most often?
Bardex Lubricath Foley Catheter (4,886), Bardex Lubri-Sil I.C. Temperature-Sensing All-Silicone Foley Catheter (4,422), Bardex I.C. Foley Catheter (3,998), Bardex Lubri-Sil I.C. All-Silicone Foley Catheter (3,111) and Bardia Foley Catheter Silicone Coated (2,412).
Which device types does it report on?
catheter, urological (antimicrobial) and accessories (26.2%), catheter, urological (16.6%), catheter, coude (16.1%) and catheter, retention type, balloon (8.4%).
Does a high count say something about the manufacturer?
Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."
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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.