Devices › Catheter, irrigation
Device brand name · Chronic catheters
Navarre Universal Drain: medical device reports filed with FDA
1,238 reports name it, 2021–2026. Manufacturer given most often on reports: C R Bard Basd -3006260740. Product code GBX.
- 1,238
- device reports naming the brand
- 0% of all MAUDE reports · about 232 a year
- 335
- reports, 12 months to August 2026
- 349 in the 12 months before
- 97.7%
- classified as malfunction
- 81.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 1,238 reports that name the brand "Navarre Universal Drain" (chronic catheters), received between March 2021 and August 2026; the manufacturer given most often on reports is C R Bard Basd -3006260740. Spellings of one product vary from report to report.
335 reports arrived in the 12 months to August 2026, close to the 349 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 (97.7%) and injury (2.3%); across all catheter, irrigation reports (product code GBX) death is recorded in 0.4% and malfunction in 81.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are fracture (56.4%), material separation (24.7%) and defective component (14.5%). The patient problems coded most often are extravasation, appropriate clinical signs, symptoms and conditions term/code not available and foreign body in patient. 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 5,889 reports carrying product code GBX. 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 |
|---|---|---|---|
| Fracturea broken bone | 698 | 56.4% | 25.7% |
| Material separation | 306 | 24.7% | 12.7% |
| Defective component | 180 | 14.5% | 6.4% |
| Breakthe device broke | 179 | 14.5% | 18.7% |
| Fluid/blood leak | 179 | 14.5% | 9.3% |
| Nonstandard device | 56 | 4.5% | 4.5% |
| Material integrity problema problem with the device material | 35 | 2.8% | 4% |
| Deformation due to compressive stress | 27 | 2.2% | 1% |
| Material puncture/hole | 20 | 1.6% | 0.5% |
| Device damaged prior to usethe device was damaged before use | 15 | 1.2% | 0.6% |
| Difficult to fold, unfold or collapse | 13 | 1.1% | 0.3% |
| Failure to advance | 13 | 1.1% | 0.4% |
| Air/gas in device | 10 | 0.8% | 0.3% |
| Obstruction of flow | 10 | 0.8% | 0.9% |
| Improper or incorrect procedure or method | 7 | 0.6% | 0.4% |
| Physical resistance/sticking | 7 | 0.6% | 0.3% |
| Packaging problem | 6 | 0.5% | 0.2% |
| Component misassembled | 5 | 0.4% | 0.4% |
| Entrapment of device | 5 | 0.4% | 0.5% |
| Collapse | 4 | 0.3% | 0.1% |
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 |
|---|---|---|
| Extravasation | 19 | 1.5% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 5 | 0.4% |
| Foreign body in patientpart of a device left in the patient | 2 | 0.2% |
| Abdominal painstomach or belly pain | 1 | 0.1% |
| Anxietyanxiety | 1 | 0.1% |
| Chronic obstructive pulmonary disease (COPD) | 1 | 0.1% |
| Fistula | 1 | 0.1% |
| Infiltration into tissue | 1 | 0.1% |
| Painpain, site not specified | 1 | 0.1% |
| Pneumothoraxa collapsed lung | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Navarre Universal Drain | Product code GBX | All MAUDE reports |
|---|---|---|---|
| Reports | 1,238 | 5,889 | 26,136,888 |
| Share of that pool | — | 21% | 0% |
| Classified as death, per 1,000 reports | 0 | 4 | 9 |
| Classified as injury | 2.3% | 17.7% | 36.2% |
| Classified as malfunction | 97.7% | 81.6% | 62.3% |
| Filed by the manufacturer | 100% | 95.5% | 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 GBX
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Navarre Opti Drain | 1,301 | 455 | 0% |
| Channel Drain | 281 | 66 | 0% |
| Blake Si Drain Hbls 10fr Rnd W/ 1/8in | 220 | 22 | 0% |
| Blake Drain Unknown Product | 159 | 7 | 6.3% |
| Flexima Catheter | 157 | 0 | 1.9% |
| Flexima? | 257 | 10 | 0.4% |
| Round Blake Hubless Silicon Drains - 3/4 Fluted | 184 | 0 | 0% |
| BLAKE Drain | 738 | 4 | 1.8% |
| Flexima APDL | 268 | 21 | 1.1% |
| Vasoview 6 Pro | 328 | 8 | 0% |
| Catheter | 244 | 9 | 3.7% |
| Cook | 271 | 6 | 2.2% |
| Onestep | 167 | 47 | 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 Navarre Universal Drain reports
How many FDA reports name Navarre Universal Drain?
1,238 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 335 in the latest 12 months.
What kinds of events are reported?
malfunction (97.7%) and injury (2.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fracture (56.4%), material separation (24.7%), defective component (14.5%), break (14.5%) and fluid/blood leak (14.5%). 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 Navarre Universal Drain 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.