Devices › Catheter, urological (antimicrobial) and accessories
Device brand name · Foley catheter
Bardex Lubri-Sil I.C. All-Silicone Temp Sensing Foley Catheter: medical device reports filed with FDA
460 reports name it, 2017–2026. Manufacturer given most often on reports: C R Bard Covington -1018233. Product code MJC.
- 460
- device reports naming the brand
- 0% of all MAUDE reports · about 51 a year
- 57
- reports, 12 months to August 2026
- 106 in the 12 months before
- 95.9%
- classified as malfunction
- 96% across the product code
- 0.2%
- classified as death, as reported
- 1 reports · not verified by FDA
460 medical device reports received by FDA name the brand "Bardex Lubri-Sil I.C. All-Silicone Temp Sensing Foley Catheter" (foley catheter); the manufacturer given most often on reports is C R Bard Covington -1018233; received from July 2017 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
57 reports arrived in the 12 months to August 2026, down 46% from 106 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 (95.9%), injury (3.9%) and death (0.2%); across all catheter, urological (antimicrobial) and accessories reports (product code MJC) death is recorded in 0% and malfunction in 96%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are material puncture/hole (26.7%), deflation problem (16.7%) and fluid/blood leak (12.6%). 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 16,445 reports carrying product code MJC. 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 |
|---|---|---|---|
| Material puncture/hole | 123 | 26.7% | 22.2% |
| Deflation problem | 77 | 16.7% | 13.1% |
| Fluid/blood leak | 58 | 12.6% | 13.1% |
| Difficult to removethe device was hard to remove | 57 | 12.4% | 8.5% |
| Material split, cut or torn | 25 | 5.4% | 3.4% |
| Leak/splashthe device leaked | 23 | 5% | 2.1% |
| Erratic or intermittent display | 19 | 4.1% | 1.1% |
| Decrease in pressure | 18 | 3.9% | 7.7% |
| Inflation problem | 18 | 3.9% | 4.9% |
| Burst container or vessel | 17 | 3.7% | 5% |
| Material protrusion/extrusion | 16 | 3.5% | 0.7% |
| Material rupture | 15 | 3.3% | 5.9% |
| Device slipped | 14 | 3% | 0.8% |
| Failure to infuse | 11 | 2.4% | 7.1% |
| Material invagination | 10 | 2.2% | 1% |
| Breakthe device broke | 9 | 2% | 2.2% |
| Device dislodged or dislocated | 9 | 2% | 1.1% |
| Device fell | 9 | 2% | 1.2% |
| Partial blockage | 9 | 2% | 1.1% |
| Inaccurate flow rate | 8 | 1.7% | 2.5% |
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 | 44 | 9.6% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 20 | 4.3% |
| Painpain, site not specified | 8 | 1.7% |
| Discomfortdiscomfort | 7 | 1.5% |
| Tissue breakdown | 5 | 1.1% |
| Bradycardiaslow heart rate | 2 | 0.4% |
| Hematuria | 2 | 0.4% |
| Hemorrhage/blood loss/bleeding | 2 | 0.4% |
| Urinary tract infectionbladder or urinary infection | 2 | 0.4% |
| Abrasion | 1 | 0.2% |
| Alteration in body temperature | 1 | 0.2% |
| Blood loss | 1 | 0.2% |
| Convulsion/seizure | 1 | 0.2% |
| Deaththe patient died; cause not stated by this term | 1 | 0.2% |
| Fever | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Bardex Lubri-Sil I.C. All-Silicone Temp Sensing Foley Catheter | Product code MJC | All MAUDE reports |
|---|---|---|---|
| Reports | 460 | 16,445 | 26,136,888 |
| Share of that pool | — | 2.8% | 0% |
| Classified as death, per 1,000 reports | 2 | 0 | 9 |
| Classified as injury | 3.9% | 3.9% | 36.2% |
| Classified as malfunction | 95.9% | 96% | 62.3% |
| Filed by the manufacturer | 98.7% | 98.3% | 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 MJC
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Bardex Lubri-Sil I.C. Temperature-Sensing All-Silicone Foley Catheter | 4,440 | 871 | 0% |
| Bardex I.C. Foley Catheter | 4,010 | 562 | 0% |
| Bardex Lubri-Sil I.C. All-Silicone Foley Catheter | 3,131 | 620 | 0% |
| Bardex I.C. Temperature Sensing Foley Catheter | 1,857 | 303 | 0% |
| Bardex I.C. Complete Care Foley Tray | 1,024 | 54 | 0% |
| Lubri-Sil I.C. Complete Care Temperature-Sensing Urine Meter Foley Tray | 281 | 32 | 0% |
| Bardex I.C. Complete Care Urine Meter Foley Tray | 243 | 23 | 0% |
| SureStep Foley Tray System Bardex IC Complete Care | 166 | 7 | 0% |
| Magic3 Intermittent Catheter with Sure-Grip Sleeve | 1,400 | 22 | 0% |
| Magic3 Intermittent Catheter | 530 | 11 | 0% |
| Surestep | 5,323 | 0 | 0.1% |
| Bardex Lubricath Foley Catheter | 4,923 | 653 | 0% |
| Latex Foley Catheter | 1,368 | 7 | 0% |
| Personal Catheter Intermittent Catheter | 684 | 12 | 0% |
| Foley Catheter | 262 | 2 | 0.8% |
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 Lubri-Sil I.C. All-Silicone Temp Sensing Foley Catheter reports
How many FDA reports name Bardex Lubri-Sil I.C. All-Silicone Temp Sensing Foley Catheter?
460 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 57 in the latest 12 months.
What kinds of events are reported?
malfunction (95.9%), injury (3.9%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material puncture/hole (26.7%), deflation problem (16.7%), fluid/blood leak (12.6%), difficult to remove (12.4%) and material split, cut or torn (5.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (98.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Bardex Lubri-Sil I.C. All-Silicone Temp Sensing 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.