BD Microtainer® Tubes with K2E (K2EDTA) 365974Recalls & reported problems
Becton, Dickinson And Company · TUBE MICRO W/MICROGARD EDTA LAV · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Microtainer K2EDTA blood collection tube has 248 reports on file, with no deaths and 20 injuries. Many describe blood clotting inside the tubes or incorrect or inadequate results, and a few describe missing components or leaks. There was 1 recall, now closed, started in May 2019, over a damaged reservoir that could leave tubes underfilled and produce erroneous results.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 250
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 250 adverse event reports that list this exact device (DI 30382903659747), received between Nov 27, 2017 and Sep 24, 2026 — classified as 20 injuries, 230 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (76 reports).
1 FDA recall record name this device's identifier.
2 other recalls cover devices cleared under the same FDA submission (K940905); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- May 13, 2019Class IITerminated
Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
Z-0057-2020 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings76
- Coagulation in Device or Device Ingredient57
- Incorrect Or Inadequate Test Results48
- Component Missing24
- Improper Chemical Reaction13
- Leak/Splash9
- Device Contamination with Chemical or Other Material7
- Device Markings/Labelling Problem6
Patient problems
- No Known Impact Or Consequence To Patient120
- No Clinical Signs, Symptoms or Conditions64
- No Consequences Or Impact To Patient38
- No Information20
- No Code Available6
- No Patient Involvement2
- Thrombus2
- Needle Stick/Puncture1
Recent adverse event reports
The 25 most recent of 250 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Improper Chemical Reaction
Report 1 of 2:It was reported while using BD Microtainer® Tubes with K2E (K2EDTA), an unspecified number of microtainers have a granular and thick appearance (partial clot formation). There was no health impact or consequences reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883637 ↗MalfunctionSep 24, 2026Improper Chemical Reaction
Report 2 of 2:It was reported while using BD Microtainer® Tubes with K2E (K2EDTA), an unspecified number of microtainers have a granular and thick appearance (partial clot formation). There was no health impact or consequences reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883634 ↗MalfunctionApr 7, 2026Coagulation in Device or Device Ingredient
IT WAS REPORTED WHILE USING BD MICROTAINER® TUBES WITH K2E (K2EDTA), CLOTTING IS SEEN IN AN UNSPECIFIED NUMBER OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24807882 ↗MalfunctionMar 26, 2026Improper Chemical Reaction
IT WAS REPORTED WHILE USING BD MICROTAINER® TUBES WITH K2E (K2EDTA), CLOTTING IS SEEN IN AN UNSPECIFIED NUMBER OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24702396 ↗MalfunctionMar 16, 2026Improper Chemical Reaction
REPORT 5 OF 7: IT WAS REPORTED AFTER USING BD MICROTAINER® TUBES WITH K2E (K2EDTA), A SAMPLE EXHIBITED CLOTTING IN ONE PATIENT. THE SAMPLE WAS REDRAWN AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24613268 ↗MalfunctionMar 16, 2026Improper Chemical Reaction
REPORT 2 OF 7. IT WAS REPORTED AFTER USING BD MICROTAINER® TUBES WITH K2E (K2EDTA), A SAMPLE EXHIBITED CLOTTING IN ONE PATIENT. THE SAMPLE WAS REDRAWN AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24613261 ↗MalfunctionMar 16, 2026Improper Chemical Reaction
REPORT 4 OF 7. IT WAS REPORTED AFTER USING BD MICROTAINER® TUBES WITH K2E (K2EDTA), A SAMPLE EXHIBITED CLOTTING IN ONE PATIENT. THE SAMPLE WAS REDRAWN AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24613259 ↗MalfunctionMar 16, 2026Improper Chemical Reaction
REPORT 7 OF 7: IT WAS REPORTED AFTER USING BD MICROTAINER® TUBES WITH K2E (K2EDTA), A SAMPLE EXHIBITED CLOTTING IN ONE PATIENT. THE SAMPLE WAS REDRAWN AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24613258 ↗MalfunctionMar 16, 2026Improper Chemical Reaction
REPORT 3 OF 7: IT WAS REPORTED AFTER USING BD MICROTAINER® TUBES WITH K2E (K2EDTA), A SAMPLE EXHIBITED CLOTTING IN ONE PATIENT. THE SAMPLE WAS REDRAWN AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24613011 ↗MalfunctionMar 16, 2026Improper Chemical Reaction
REPORT 6 OF 7. IT WAS REPORTED AFTER USING BD MICROTAINER® TUBES WITH K2E (K2EDTA), A SAMPLE EXHIBITED CLOTTING IN ONE PATIENT. THE SAMPLE WAS REDRAWN, AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24613010 ↗MalfunctionMar 16, 2026Improper Chemical Reaction
REPORT 1 OF 7: IT WAS REPORTED AFTER USING BD MICROTAINER® TUBES WITH K2E (K2EDTA), A SAMPLE EXHIBITED CLOTTING IN ONE PATIENT. THE SAMPLES WAS REDRAWN AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24613009 ↗MalfunctionDec 30, 2025Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient
IT WAS REPORTED THAT WHILE USING THE BD MICROTAINER® TUBES WITH K2E (K2EDTA) THAT THERE WAS AN UNSPECIFED AMOUNT OF TUBES WITH CLOTTING. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23927653 ↗MalfunctionDec 17, 2025Off-Label Use; Device Ingredient or Reagent Problem; Improper Chemical Reaction; Off-Label Use; Device Ingredient or Reagent Problem; Improper Chemical Reaction
IT WAS REPORTED WHILE USING BD MICROTAINER® TUBES WITH K2E (K2EDTA), AN UNSPECIFIED NUMBER OF TUBES UNDERWENT HEMOLYSIS, AND THE PLASMA DID NOT SEPARATE PROPERLY. UPON INSPECTION, AFTER USE, THE CUSTOMER NOTICED THAT THE TUBES WERE EXPIRED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23831309 ↗MalfunctionSep 9, 2025Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient
IT WAS REPORTED WHILE USING BD MICROTAINER® TUBES WITH K2E (K2EDTA), SAMPLE CLOTTING WAS SEEN IN 8 TUBES RESULTING IN SAMPLE RECOLLECTION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23010924 ↗MalfunctionSep 2, 2025Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient
IT WAS REPORTED WHILE USING BD MICROTAINER® TUBES WITH K2E (K2EDTA), SAMPLE CLOTTING WAS SEEN IN 8 TUBES RESULTING IN SAMPLE RECOLLECTION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22945618 ↗MalfunctionJul 7, 2025Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient
IT WAS REPORTED WHILE USING BD MICROTAINER® TUBES WITH K2E (K2EDTA), AN UNSPECIFIED NUMBER OF SAMPLES CLOTTED UPON RECEIPT BY THE LAB. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22414533 ↗MalfunctionMay 21, 2025Improper Chemical Reaction; Improper Chemical Reaction
REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD MICROTAINER® TUBES WITH K2E (K2EDTA), 1 PATIENT SAMPLE WAS CLOTTED. TWO PREVIOUS CLOTTED SAMPLES WERE ALSO COLLECTED. THE SAMPLE WAS RECOLLECTED. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061426 ↗MalfunctionMay 21, 2025Improper Chemical Reaction; Improper Chemical Reaction
REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD MICROTAINER® TUBES WITH K2E (K2EDTA) 2 PATIENT SAMPLES (SAME PATIENT) WERE CLOTTED. THE SAMPLE WAS RECOLLECTED. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061411 ↗MalfunctionFeb 21, 2025Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient
IT WAS REPORTED AFTER USING BD MICROTAINER® TUBES WITH K2E (K2EDTA) 1 SAMPLE EXHIBITED CLOTTING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21432940 ↗MalfunctionNov 19, 2024Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient
IT WAS REPORTING WHILE USING BD MICROTAINER® TUBES WITH K2E (K2EDTA), THE BLOOD SAMPLES WERE CLOTTING. THIS OCCURRED WITH AN UNSPECIFIED NUMBER OF TUBES. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20717703 ↗MalfunctionJun 25, 2024Component Missing; Component Missing
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD MICROTAINER® TUBES WITH K2E (K2EDTA) DID NOT CONTAIN ADDITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19610443 ↗MalfunctionMay 14, 2024Component Missing; Component Missing
IT WAS REPORTED THAT DURING USE WITH THE BD MICROTAINER® TUBES WITH K2E (K2EDTA), THE TUBE DID NOT CONTAIN ANTICOAGULANT, WHICH LED TO COAGULATION OF THE SAMPLE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19315941 ↗MalfunctionApr 30, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED PRIOR TO USING THE BD MICROTAINER® TUBES WITH K2E (K2EDTA) THE LABEL ON THE BOX WAS TORN. THERE WAS NO REPORT OF IMPACT ON THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19212055 ↗MalfunctionApr 29, 2024Component Missing; Component Missing
IT WAS REPORTED WHEN USING THE BD MICROTAINER® TUBES WITH K2E (K2EDTA) AN UNSPECIFIED NUMBER OF TUBES WERE MISSING ADDITIVE CAUSING CLOTTING WITHIN THE TUBES. SAMPLE RECOLLECTION OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19203595 ↗MalfunctionApr 29, 2024Component Missing; Component Missing
IT WAS REPORTED WHEN USING THE BD MICROTAINER® TUBES WITH K2E (K2EDTA) AN UNSPECIFIED NUMBER OF TUBES WERE MISSING ADDITIVE CAUSING CLOTTING WITHIN THE TUBES. SAMPLE RECOLLECTION OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19203591 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K940905. One submission often covers many models, so check the product and lot details in each record.
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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