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FDA product code JKA · class 2 · Clinical Chemistry
Tubes, vials, systems, serum separators, blood collection: medical device reports filed with FDA
49,074 reports carry this product code, 1993–2026; 30 brands with a page.
- 49,074
- reports with this product code
- 0.2% of all MAUDE reports
- 6,232
- reports, 12 months to August 2026
- 5,081 in the 12 months before
- 96.7%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0.9% across all reports
Product code JKA is FDA's classification for "Tubes, vials, systems, serum separators, blood collection" (clinical Chemistry panel), a class 2 device. 49,074 medical device reports carry this product code, 0.2% of the MAUDE database, from October 1993 to August 2026.
6,232 reports arrived in the 12 months to August 2026, up 23% from 5,081 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 (96.7%), injury (2.6%) and other (0.5%). 30 brand names with a page on this site carry this code; the brands table is 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."
Brands with this product code
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."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| Becton Dickinson And Bd | 15,459 | 31.5% |
| Becton Dickinson & Bd | 9,439 | 19.2% |
| Becton Dickinson & Broken Bow | 7,858 | 16% |
| Becton Dickinson | 7,766 | 15.8% |
| Becton Dickinson & Franklin Lakes | 3,043 | 6.2% |
| Bd Caribe | 973 | 2% |
| Becton Dickinson Ind Cirurgicas Ltda | 617 | 1.3% |
| Smiths Medical Asd | 440 | 0.9% |
| Becton Dickinson Infusion Therapy Systems | 335 | 0.7% |
| Becton Dickinson Medical Singapore | 266 | 0.5% |
| Bd Suzhou | 235 | 0.5% |
| Becton Dickinson And | 227 | 0.5% |
| Bd Rapis Diagnostics Suzhou | 164 | 0.3% |
| Bd | 155 | 0.3% |
| Icu Medical | 115 | 0.2% |
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 and report source
Event type
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Short fill | 7,918 | 16.1% |
| Incorrect, inadequate or imprecise result or readings | 6,636 | 13.5% |
| Leak/splashthe device leaked | 6,478 | 13.2% |
| Device contamination with chemical or other material | 5,356 | 10.9% |
| Volume accuracy problem | 2,864 | 5.8% |
| Fluid/blood leak | 2,607 | 5.3% |
| Incorrect or inadequate test results | 2,379 | 4.8% |
| Device ingredient or reagent problem | 2,332 | 4.8% |
| Device markings/labelling problema problem with the device markings or label | 1,924 | 3.9% |
| Overfill | 1,738 | 3.5% |
| Coagulation in device or device ingredient | 1,558 | 3.2% |
| Material deformation | 1,541 | 3.1% |
| Breakthe device broke | 1,238 | 2.5% |
| Product quality problem | 931 | 1.9% |
| Separation problem | 830 | 1.7% |
| Difficult to insertthe device was hard to insert | 687 | 1.4% |
| Difficult or delayed activation | 673 | 1.4% |
| Component missing | 594 | 1.2% |
| Crackthe device cracked | 507 | 1% |
| Improper chemical reaction | 401 | 0.8% |
Questions about tubes, vials, systems, serum separators, blood collection reports
What is product code JKA?
FDA's classification code for "Tubes, vials, systems, serum separators, blood collection", class 2, reviewed by the clinical Chemistry panel. Every device report carries the product code of the device involved.
How many reports carry this code?
49,074 reports through August 2026, 6,232 of them in the latest 12 months.
Which brands appear most often?
BD Vacutainer SST Blood Collection Tubes (4,580), BD Vacutainer Buffered Sodium Citrate (9NC) Blood Collection Tubes (1,536), BD Vacutainer SST (1,437), BD Vacutainer Serum Blood Collection Tubes (1,305) and BD Vacutainer EDTA 2K (1,039). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
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." Brands differ in how many are in use, how long they have been sold and how reports are collected.
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. 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.