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Device brand name · Blood specimen collection device
BD Vacutainer K2 EDTA (K2E) 5.4mg Blood Collection Tubes: medical device reports filed with FDA
1,021 reports name it, 2018–2026. Manufacturer given most often on reports: Becton Dickinson & Broken Bow. Product code JKA.
- 1,021
- device reports naming the brand
- 0% of all MAUDE reports · about 124 a year
- 173
- reports, 12 months to August 2026
- 203 in the 12 months before
- 99.6%
- classified as malfunction
- 96.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 1,021 reports that name the brand "BD Vacutainer K2 EDTA (K2E) 5.4mg Blood Collection Tubes" (blood specimen collection device), received between April 2018 and August 2026; the manufacturer given most often on reports is Becton Dickinson & Broken Bow. Spellings of one product vary from report to report.
173 reports arrived in the 12 months to August 2026, down 15% from 203 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 (99.6%) and injury (0.4%); across all tubes, vials, systems, serum separators, blood collection reports (product code JKA) death is recorded in 0% and malfunction in 96.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are short fill (26.3%), device contamination with chemical or other material (25.7%) and leak/splash (9.4%). The patient problems coded most often are no patient involvement, chemical exposure and exposure to body fluids. 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 49,074 reports carrying product code JKA. 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 |
|---|---|---|---|
| Short fill | 269 | 26.3% | 16.1% |
| Device contamination with chemical or other material | 262 | 25.7% | 10.9% |
| Leak/splashthe device leaked | 96 | 9.4% | 13.2% |
| Coagulation in device or device ingredient | 84 | 8.2% | 3.2% |
| Device markings/labelling problema problem with the device markings or label | 53 | 5.2% | 3.9% |
| Volume accuracy problem | 49 | 4.8% | 5.8% |
| Material protrusion/extrusion | 46 | 4.5% | 0.5% |
| Incorrect, inadequate or imprecise result or readings | 37 | 3.6% | 13.5% |
| Material deformation | 32 | 3.1% | 3.1% |
| Difficult to insertthe device was hard to insert | 29 | 2.8% | 1.4% |
| Premature separation | 20 | 2% | 0.6% |
| Fluid/blood leak | 18 | 1.8% | 5.3% |
| Incorrect or inadequate test results | 16 | 1.6% | 4.8% |
| Crackthe device cracked | 14 | 1.4% | 1% |
| Separation problem | 13 | 1.3% | 1.7% |
| Device ingredient or reagent problem | 10 | 1% | 4.8% |
| Improper chemical reaction | 9 | 0.9% | 0.8% |
| Contamination | 6 | 0.6% | 0.2% |
| Component misassembled | 5 | 0.5% | 0.1% |
| Defective component | 5 | 0.5% | 0.3% |
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 | 20 | 2% |
| Chemical exposure | 1 | 0.1% |
| Exposure to body fluids | 1 | 0.1% |
| Local reaction | 1 | 0.1% |
| Needle stick/puncture | 1 | 0.1% |
| Painpain, site not specified | 1 | 0.1% |
| Swelling/ edema | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | BD Vacutainer K2 EDTA (K2E) 5.4mg Blood Collection Tubes | Product code JKA | All MAUDE reports |
|---|---|---|---|
| Reports | 1,021 | 49,074 | 26,136,888 |
| Share of that pool | — | 2.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 0.4% | 2.6% | 36.2% |
| Classified as malfunction | 99.6% | 96.7% | 62.3% |
| Filed by the manufacturer | 100% | 98.4% | 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 JKA
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 BD Vacutainer K2 EDTA (K2E) 5.4mg Blood Collection Tubes reports
How many FDA reports name BD Vacutainer K2 EDTA (K2E) 5.4mg Blood Collection Tubes?
1,021 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 173 in the latest 12 months.
What kinds of events are reported?
malfunction (99.6%) and injury (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
short fill (26.3%), device contamination with chemical or other material (25.7%), leak/splash (9.4%), coagulation in device or device ingredient (8.2%) and device markings/labelling problem (5.2%). 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 BD Vacutainer K2 EDTA (K2E) 5.4mg Blood Collection Tubes 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.