Devices › Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
Device brand name · Hemostatic valve
Copilot Bleedback Control Valve: medical device reports filed with FDA
215 reports name it, 2011–2024. Manufacturer given most often on reports: Av-Temecula-Ct. Product code DTL.
- 215
- device reports naming the brand
- 0% of all MAUDE reports · about 14 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 93.5%
- classified as malfunction
- 90.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
215 medical device reports received by FDA name the brand "Copilot Bleedback Control Valve" (hemostatic valve); the manufacturer given most often on reports is Av-Temecula-Ct; received from February 2011 to June 2024. 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, and none 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 (93.5%) and injury (6.5%); across all adaptor, stopcock, manifold, fitting, cardiopulmonary bypass reports (product code DTL) death is recorded in 0.8% and malfunction in 90.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are leak/splash (57.2%), loose or intermittent connection (22.3%) and device markings/labelling problem (4.7%). The patient problems coded most often are no patient involvement, air embolism and cardiac arrest. 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 2,159 reports carrying product code DTL. 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 |
|---|---|---|---|
| Leak/splashthe device leaked | 123 | 57.2% | 33.3% |
| Loose or intermittent connection | 48 | 22.3% | 8.6% |
| Device markings/labelling problema problem with the device markings or label | 10 | 4.7% | 0.5% |
| Difficult to position | 4 | 1.9% | 0.5% |
| Difficult to removethe device was hard to remove | 3 | 1.4% | 0.6% |
| Improper or incorrect procedure or method | 3 | 1.4% | 1% |
| Physical resistance/sticking | 3 | 1.4% | 1% |
| Crackthe device cracked | 2 | 0.9% | 2.3% |
| Detachment of device component | 2 | 0.9% | 2.7% |
| Difficult to insertthe device was hard to insert | 2 | 0.9% | 0.3% |
| Product quality problem | 2 | 0.9% | 0.1% |
| Device contamination with chemical or other material | 1 | 0.5% | 1.1% |
| Device damaged by another device | 1 | 0.5% | 0% |
| Device operates differently than expectedthe device behaved unexpectedly | 1 | 0.5% | 0.7% |
| Difficult to advance | 1 | 0.5% | 0.3% |
| Tear, rip or hole in device packaging | 1 | 0.5% | 1.2% |
| Unsealed device packaging | 1 | 0.5% | 0.7% |
| Unstable | 1 | 0.5% | 0.5% |
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 | 14 | 6.5% |
| Air embolism | 9 | 4.2% |
| Cardiac arrestthe heart stopped | 4 | 1.9% |
| Bradycardiaslow heart rate | 2 | 0.9% |
| Non specific ekg/ECG changes | 2 | 0.9% |
| Embolism | 1 | 0.5% |
| Myocardial infarctionheart attack | 1 | 0.5% |
| Respiratory failurethe lungs could not supply enough oxygen | 1 | 0.5% |
| Ventricular fibrillationa chaotic rhythm from the lower heart chambers | 1 | 0.5% |
| Ventricular tachycardiaa fast rhythm from the lower heart chambers | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Copilot Bleedback Control Valve | Product code DTL | All MAUDE reports |
|---|---|---|---|
| Reports | 215 | 2,159 | 26,136,888 |
| Share of that pool | — | 10% | 0% |
| Classified as death, per 1,000 reports | 0 | 8 | 9 |
| Classified as injury | 6.5% | 6.8% | 36.2% |
| Classified as malfunction | 93.5% | 90.7% | 62.3% |
| Filed by the manufacturer | 100% | 95.7% | 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 DTL
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Copilot | 226 | 26 | 0% |
| Merit Custom Kit | 1,590 | 13 | 0.1% |
| Boston Scientific | 580 | 5 | 3.3% |
| Navilyst Medical | 252 | 0 | 0.4% |
| Indeflator | 356 | 23 | 0% |
| AngioDynamics | 174 | 14 | 1.7% |
| Custom Tubing Pack | 1,039 | 353 | 1.1% |
| Deroyal | 587 | 14 | 0.7% |
| Attain | 459 | 0 | 1.5% |
| Cardiovascular Procedure Kit | 553 | 0 | 1.3% |
| Acist | 348 | 14 | 10.6% |
| Bulk Non Ster Xcoat Delph Pump | 266 | 0 | 0.4% |
| Hlm Tubing Set W/Bioline Coating | 439 | 0 | 7.1% |
| Medex | 202 | 8 | 0% |
| Stopcock | 164 | 16 | 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 Copilot Bleedback Control Valve reports
How many FDA reports name Copilot Bleedback Control Valve?
215 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 (93.5%) and injury (6.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
leak/splash (57.2%), loose or intermittent connection (22.3%), device markings/labelling problem (4.7%), difficult to position (1.9%) and difficult to remove (1.4%). 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 Copilot Bleedback Control Valve 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.