Tubes, vacuum sample, with anticoagulant: medical device reports filed with FDA

2,002 reports carry this product code, 1999–2026; 15 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

2,002
reports with this product code: 0% of all MAUDE reports; 521
reports, 12 months to August 2026: 578 in the 12 months before; 99.6%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code GIM is FDA's classification for "Tubes, vacuum sample, with anticoagulant" (clinical Chemistry panel), a class 2 device. 2,002 medical device reports carry this product code, 0% of the MAUDE database, from April 1999 to August 2026.

521 reports arrived in the 12 months to August 2026, down 10% from 578 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 (0.3%). 15 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

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
BD Vacutainer K2 EDTA (K2E) 5.4mg Blood Collection Tubes	427	173	0%	99.6%
BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tubes	401	103	0%	100%
BD Vacutainer K2 EDTA (K2E) 7.2mg Blood Collection Tubes	185	103	0%	99.6%
BD MiniDraw H&H Capillary Blood Collection Tube	156	76	0%	100%
BD Vacutainer K2 EDTA (K2E) 10.8mg Blood Collection Tubes	141	25	0%	99.3%
Bd Vacutainer K2 Edta K2e Blood Collection Tubes	56	0	0%	100%
Bd Vacutainer K2 Edta K2e Plus Blood Collection Tubes	40	15	0%	100%
BD Vacutainer PST Gel and Lithium HeparinN 56 Units	6	55	0%	99.4%
BD Vacutainer EDTA 2K	2	53	0.1%	99.9%
Bd Vacutainer 9nc 0 129m Plus Blood Collection Tubes	1	12	0%	100%
Bd Vacutainer Buffered Sodium Citrate 9nc Blood Collection Tube	1	1	0%	100%
BD Vacutainer K3E 5.4mg Plus Blood Collection Tubes	1	23	0%	99.5%
BD Vacutainer PPT Plasma Preparation Tube K2E 9.0 mg	1	56	0%	100%
Bd Vacutainer Precisionglide Multiple Sample Needle	1	0	0%	98.6%
BD Vacutainer Serum Blood Collection Tubes	1	119	0%	99.8%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Becton Dickinson & Broken Bow	857	42.8%
Becton Dickinson & Franklin Lakes	326	16.3%
Becton Dickinson	256	12.8%
Bd Caribe	113	5.6%
Becton Dickinson And Bd	67	3.3%
Becton Dickinson And	3	0.1%
Becton Dickinson & Bd	2	0.1%
International Technidyne	1	0%

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

Death0%0

Injury0.3%7

Malfunction99.6%1,994

Other0%1

Not given0%0

Who filed

Manufacturer report99.6%1,993

Voluntary report0%1

User facility report0%0

Distributor report0%0

Not given0.4%8

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Short fill	652	32.6%
Device contamination with chemical or other material	301	15%
Leak/splashthe device leaked	203	10.1%
Coagulation in device or device ingredient	183	9.1%
Volume accuracy problem	112	5.6%
Improper chemical reaction	86	4.3%
Incorrect, inadequate or imprecise result or readings	77	3.8%
Device markings/labelling problema problem with the device markings or label	61	3%
Material protrusion/extrusion	59	2.9%
Clumping in device or device ingredient	54	2.7%
Material deformation	49	2.4%
Incorrect or inadequate test results	40	2%
Premature separation	37	1.8%
Filling problem	36	1.8%
Device ingredient or reagent problem	34	1.7%
Difficult to insertthe device was hard to insert	31	1.5%
Excessive heating	31	1.5%
Crackthe device cracked	22	1.1%
Fluid/blood leak	22	1.1%
Overfill	20	1%

Questions about tubes, vacuum sample, with anticoagulant reports

What is product code GIM?

FDA's classification code for "Tubes, vacuum sample, with anticoagulant", 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?

2,002 reports through August 2026, 521 of them in the latest 12 months.

Which brands appear most often?

BD Vacutainer K2 EDTA (K2E) 5.4mg Blood Collection Tubes (427), BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tubes (401), BD Vacutainer K2 EDTA (K2E) 7.2mg Blood Collection Tubes (185), BD MiniDraw H&H Capillary Blood Collection Tube (156) and BD Vacutainer K2 EDTA (K2E) 10.8mg Blood Collection Tubes (141). 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.