BD Vacutainer® K2 EDTA (K2E) 3.6mg Blood Collection Tubes 367841Recalls & reported problems
Becton, Dickinson And Company · TUBE K2EDTA PLH 13X75 2.0 PLBL LAV · Class 2
All models of BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tubes (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Vacutainer K2 EDTA blood collection tube is used to draw blood. Its 658 reports mostly describe tubes filling with too little blood, and some mention leaks, contamination or clotting. There are no deaths or injuries reported. One recall started in August 2017 and is closed; it covered part of a lot with too little anticoagulant additive, which could lead to wrong test 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
- 664
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 664 adverse event reports that list this exact device (DI 30382903678410), received between Oct 30, 2017 and Sep 30, 2026 — classified as 664 malfunctions.
The most frequently reported specific device problem is “Short Fill” (309 reports).
1 FDA recall record name this device's identifier.
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
- Aug 29, 2017Class IITerminated
A limited portion of the lot was manufactured with less than the required amount of K2EDTA additive, an anticoagulant, which may cause erroneous results that could lead to specimen recollection and potential delay of treatment or misdiagnosis/mismanagement of treatment and serious complications, such as failure to detect thrombocytosis or postponing surgery.
Z-0968-2018 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Short Fill309
- Volume Accuracy Problem122
- Device Contamination with Chemical or Other Material58
- Leak/Splash44
- Coagulation in Device or Device Ingredient35
- Incorrect, Inadequate or Imprecise Result or Readings32
- Device Markings/Labelling Problem27
- Material Deformation23
Patient problems
- No Clinical Signs, Symptoms or Conditions392
- No Known Impact Or Consequence To Patient213
- No Consequences Or Impact To Patient37
- No Information13
- No Patient Involvement7
- Skin Inflammation/ Irritation3
- Pain2
- Discomfort1
Recent adverse event reports
The 25 most recent of 664 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955061 ↗MalfunctionSep 28, 2026Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926540 ↗MalfunctionSep 28, 2026Short Fill
It was reported that when using the BD Vacutainer® K2 EDTA (K2E) 3.6mg Blood Collection Tubes, one (1) tube underfilled, requiring recollection. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915166 ↗MalfunctionSep 24, 2026Overfill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890857 ↗MalfunctionSep 24, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889790 ↗MalfunctionSep 23, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870507 ↗MalfunctionSep 16, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793763 ↗MalfunctionSep 11, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50733222 ↗MalfunctionJun 30, 2026Short Fill
REPORT 3 OF 4. IT WAS REPORTED THAT WHILE DRAWING BLOOD FROM ONE PATIENT USING BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES, ONE TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25673045 ↗MalfunctionJun 30, 2026Short Fill
REPORT 4 OF 4. IT WAS REPORTED THAT WHILE DRAWING BLOOD FROM ONE PATIENT USING BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES, ONE TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25673040 ↗MalfunctionJun 30, 2026Short Fill
REPORT 1 OF 4. IT WAS REPORTED THAT WHILE DRAWING BLOOD FROM ONE PATIENT USING BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES, ONE TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25673039 ↗MalfunctionJun 30, 2026Short Fill
REPORT 2 OF 4 IT WAS REPORTED THAT WHILE DRAWING BLOOD FROM ONE PATIENT USING BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES, ONE TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25673037 ↗MalfunctionJun 30, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25671885 ↗MalfunctionJun 3, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES, FOREIGN MATTER WAS FOUND IN ONE (1) TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25383645 ↗MalfunctionJun 1, 2026Short Fill
REPORT 1 OF 4. IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25356359 ↗MalfunctionJun 1, 2026Short Fill
REPORT 2 OF 4: IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25356344 ↗MalfunctionJun 1, 2026Short Fill
REPORT 3 OF 4. IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25353725 ↗MalfunctionJun 1, 2026Short Fill
REPORT 4 OF 4: IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25353722 ↗MalfunctionMay 28, 2026Short Fill
REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25323314 ↗MalfunctionMay 28, 2026Short Fill
REPORT 2 OF 2 IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25323303 ↗MalfunctionMay 26, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES, 100 TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25291985 ↗MalfunctionMay 26, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25285231 ↗MalfunctionMay 19, 2026Device Ingredient or Reagent Problem
REPORT 1 OF 3 IT WAS REPORTED WHILE USING [BRAND NAME] THERE WAS POOR BARRIER SEPARATION SEEN IN (X) TUBE(S). NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25222133 ↗MalfunctionMay 19, 2026Device Ingredient or Reagent Problem
REPORT 2 OF 3: IT WAS REPORTED WHILE USING [BRAND NAME] THERE WAS POOR BARRIER SEPARATION SEEN IN (X) TUBE(S). NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25222127 ↗MalfunctionMay 19, 2026Device Ingredient or Reagent Problem
REPORT 1 OF 3: IT WAS REPORTED WHILE USING [BRAND NAME] THERE WAS POOR BARRIER SEPARATION SEEN IN (X) TUBE(S). NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25222125 ↗
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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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