BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes 367856Recalls & reported problems
Becton, Dickinson And Company · TUBE K2EDTA PLH 13X75 3.0 PLBL LAV · Class 2
All models of BD Vacutainer K2 EDTA (K2E) 5.4mg Blood Collection Tubes (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Vacutainer K2 EDTA blood collection tube is a tube used to draw and hold blood samples. The 1,019 reports often describe tubes that were underfilled, contaminated, leaking or had blood clotting inside, and one describes erroneous platelet counts that were normal on redraw. There are 4 injury reports and no deaths. Reports fell from 178 in the prior 12 months to 111 in the last 12. No recalls name this device.
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
- 1,010
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,010 adverse event reports that list this exact device (DI 30382903678564), received between Nov 27, 2017 and Sep 29, 2026 — classified as 4 injuries, 1,006 malfunctions.
The most frequently reported specific device problem is “Short Fill” (247 reports).
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
Most reported problems
Device problems
- Short Fill247
- Device Contamination with Chemical or Other Material243
- Leak/Splash101
- Coagulation in Device or Device Ingredient94
- Device Markings/Labelling Problem64
- Volume Accuracy Problem59
- Material Protrusion/Extrusion44
- Incorrect, Inadequate or Imprecise Result or Readings41
Patient problems
- No Clinical Signs, Symptoms or Conditions630
- No Known Impact Or Consequence To Patient268
- No Consequences Or Impact To Patient78
- No Patient Involvement17
- No Information13
- No Code Available2
- Chemical Exposure1
- Exposure to Body Fluids1
Recent adverse event reports
The 25 most recent of 1,010 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Short Fill
It was reported while using BD Vacutainer® K2 EDTA (K2E) 5.4mg 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 50935963 ↗MalfunctionSep 14, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761311 ↗MalfunctionSep 14, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761307 ↗MalfunctionSep 14, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761304 ↗MalfunctionSep 14, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761246 ↗MalfunctionSep 14, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761243 ↗MalfunctionSep 14, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50756465 ↗MalfunctionSep 9, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50698866 ↗MalfunctionSep 9, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50693877 ↗MalfunctionAug 4, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50133856 ↗MalfunctionAug 4, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50132920 ↗MalfunctionJun 22, 2026Fluid/Blood Leak
IT WAS REPORTED THAT DURING CENTRIFUGATION OF BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, ONE TUBE BROKE RESULTING IN SAMPLE LEAKAGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25578776 ↗MalfunctionJun 18, 2026Short Fill
IT WAS REPORTED DURING USE FIVE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, HAD INSUFFICIENT NEGATIVE PRESSURE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25551951 ↗MalfunctionJun 12, 2026Coagulation in Device or Device Ingredient
IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES APPEARED TO CLOTTED POST CENTRIFUGATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25491615 ↗MalfunctionJun 10, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, ONE (1) TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25453121 ↗MalfunctionJun 2, 2026Material Protrusion/Extrusion
IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, UNSPECIFIED NUMBER OF TUBES WERE FOUND TO EXHIBIT A PLASTIC SPIKE PROTRUDING FROM THE INTERIOR OF THE TUBE. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25365356 ↗MalfunctionMay 26, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, FOREIGN MATTER WAS FOUND IN 341 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25293139 ↗MalfunctionMay 19, 2026Fluid/Blood Leak
REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF FILLED TUBES WERE STORED AT -80 °C, WHICH RESULTED IN BREAKAGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25222124 ↗MalfunctionMay 19, 2026Fluid/Blood Leak
REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF FILLED TUBES WERE STORED AT -80 °C, WHICH RESULTED IN BREAKAGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25222123 ↗MalfunctionMay 15, 2026Improper Chemical Reaction
IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, CLOTS WERE OBSERVED IN 3 SPECIMENS. NO ADVERSE IMPACT WAS REPORTED REGARDING PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25191204 ↗MalfunctionMay 14, 2026Device Markings/Labelling Problem
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF UNITS HAD AN INCORRECT LABEL ON THE PACKAGING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25167034 ↗MalfunctionMay 13, 2026Device Contamination with Chemical or Other Material
REPORT 2 OF 2. IT WAS REPORTED THAT PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, FOREIGN MATTER (BLACK DOT) WAS SEEN INSIDE OF 67 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25164850 ↗MalfunctionMay 13, 2026Device Contamination with Chemical or Other Material
REPORT 1 OF 2. IT WAS REPORTED THAT PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, FOREIGN MATTER (BLACK DOT) WAS SEEN INSIDE OF 100 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25164834 ↗MalfunctionMay 12, 2026Short Fill
IT WAS REPORTED THAT WHEN USING BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, 1 TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25148811 ↗MalfunctionMay 6, 2026Device Contamination with Chemical or Other Material
REPORT 2 OF 2: IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, FOREIGN MATTER WAS FOUND IN 276 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25107177 ↗
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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
- 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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