Devices › Blood/plasma collection device for dna testing
Device brand name · Blood specimen collection device
BD Vacutainer PPT Plasma Preparation Tube K2E 9.0 mg: medical device reports filed with FDA
501 reports name it, 2018–2026. Manufacturer given most often on reports: Becton Dickinson & Broken Bow. Product code PJE.
- 501
- device reports naming the brand
- 0% of all MAUDE reports · about 61 a year
- 56
- reports, 12 months to August 2026
- 171 in the 12 months before
- 100%
- classified as malfunction
- 100% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
501 medical device reports received by FDA name the brand "BD Vacutainer PPT Plasma Preparation Tube K2E 9.0 mg" (blood specimen collection device); the manufacturer given most often on reports is Becton Dickinson & Broken Bow; received from April 2018 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
56 reports arrived in the 12 months to August 2026, down 67% from 171 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 (100%); across all blood/plasma collection device for dna testing reports (product code PJE) death is recorded in 0% and malfunction in 100%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are incorrect, inadequate or imprecise result or readings (24.2%), device contamination with chemical or other material (20.2%) and device ingredient or reagent problem (17.4%). The patient problems coded most often are no patient involvement 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 585 reports carrying product code PJE. 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 |
|---|---|---|---|
| Incorrect, inadequate or imprecise result or readings | 121 | 24.2% | 42.7% |
| Device contamination with chemical or other material | 101 | 20.2% | 13.2% |
| Device ingredient or reagent problem | 87 | 17.4% | 25.3% |
| Leak/splashthe device leaked | 56 | 11.2% | 2.2% |
| Material deformation | 42 | 8.4% | 1% |
| Incorrect or inadequate test results | 38 | 7.6% | 1.5% |
| Device markings/labelling problema problem with the device markings or label | 29 | 5.8% | 3.8% |
| Short fill | 26 | 5.2% | 6% |
| Fluid/blood leak | 11 | 2.2% | 0.7% |
| Volume accuracy problem | 11 | 2.2% | 1.5% |
| Deformation due to compressive stress | 6 | 1.2% | 0% |
| Improper or incorrect procedure or method | 6 | 1.2% | 0.3% |
| Coagulation in device or device ingredient | 5 | 1% | 0.7% |
| Improper chemical reaction | 4 | 0.8% | 0.5% |
| Missing information | 4 | 0.8% | 0.3% |
| Particulates | 4 | 0.8% | 0.7% |
| Component missing | 3 | 0.6% | 0.3% |
| Breakthe device broke | 2 | 0.4% | 0.3% |
| Contamination | 2 | 0.4% | 0.2% |
| Overfill | 2 | 0.4% | 0.2% |
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 | 17 | 3.4% |
| Exposure to body fluids | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | BD Vacutainer PPT Plasma Preparation Tube K2E 9.0 mg | Product code PJE | All MAUDE reports |
|---|---|---|---|
| Reports | 501 | 585 | 26,136,888 |
| Share of that pool | — | 85.6% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 0% | 0% | 36.2% |
| Classified as malfunction | 100% | 100% | 62.3% |
| Filed by the manufacturer | 100% | 100% | 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 PJE
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Bd Vacutainer Ppt Plasma Preparation Tubes K2e Edta 9 0 Mg | 150 | 1 | 0% |
| Bd Vacutainer 9nc 0 129m Plus Blood Collection Tubes | 324 | 12 | 0% |
| Bd Vacutainer Eclipse Signal Blood Collection Needle | 156 | 8 | 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 BD Vacutainer PPT Plasma Preparation Tube K2E 9.0 mg reports
How many FDA reports name BD Vacutainer PPT Plasma Preparation Tube K2E 9.0 mg?
501 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 56 in the latest 12 months.
What kinds of events are reported?
malfunction (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
incorrect, inadequate or imprecise result or readings (24.2%), device contamination with chemical or other material (20.2%), device ingredient or reagent problem (17.4%), leak/splash (11.2%) and material deformation (8.4%). 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 BD Vacutainer PPT Plasma Preparation Tube K2E 9.0 mg 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.