BD Vacutainer® K2 EDTA (K2E) Plus Blood Collection Tubes 366643Recalls & reported problems
Becton, Dickinson U.K. Limited · TUBE EDTA PLH 16X100 10.0 SLBL USA LAV · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Vacutainer K2 EDTA Plus blood collection tube has 124 adverse event reports, with no deaths or injuries. Reports most often describe tubes that are underfilled, leak blood, contain foreign matter, or cause samples to clot. 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
- 124
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 124 adverse event reports that list this exact device (DI 30382903666431), received between Dec 1, 2017 and Apr 28, 2026 — classified as 124 malfunctions.
The most frequently reported specific device problem is “Short Fill” (23 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 Fill23
- Leak/Splash17
- Device Contamination with Chemical or Other Material14
- Incorrect, Inadequate or Imprecise Result or Readings14
- Device Ingredient or Reagent Problem10
- Coagulation in Device or Device Ingredient7
- Device Markings/Labelling Problem7
- Incorrect Or Inadequate Test Results7
Patient problems
- No Clinical Signs, Symptoms or Conditions60
- No Known Impact Or Consequence To Patient52
- No Information6
- No Consequences Or Impact To Patient5
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 124 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES, ONE TUBE EXHIBITED FOREIGN MATTER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25017613 ↗MalfunctionApr 17, 2026Improper Chemical Reaction
IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF SAMPLES ARE CLOTTING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912797 ↗MalfunctionFeb 20, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES, SIX (6) TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24407897 ↗MalfunctionDec 15, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBE, BLOOD LEAKAGE OCCURS WHEN THE TUBE IS REMOVED FROM THE ACQUISITION DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23803972 ↗MalfunctionDec 12, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AFTER ONE (1) BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBE WAS FILLED, BLOOD WAS LEAKING FROM THE CAP, REQUIRING RECOLLECTION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23794663 ↗MalfunctionDec 9, 2025Crack; Crack
IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES THE TUBE WALL OF 512 DEVICES CRACKED FOLLOWING STORAGE OF THE SPECIMENS IN -80C TEMPERATURES. THE SPECIMENS WERE RECOLLECTED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23756654 ↗MalfunctionNov 24, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES THE TUBE WALL OF 512 DEVICES CRACKED FOLLOWING STORAGE OF THE SPECIMENS IN -80C TEMPERATURES. THE SPECIMENS WERE RECOLLECTED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23632978 ↗MalfunctionOct 15, 2025Short Fill; Short Fill
IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES THERE WAS LOW SAMPLE COLLECTED IN 2 DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23301264 ↗MalfunctionSep 8, 2025Improper Chemical Reaction; Improper Chemical Reaction
IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES THE SAMPLE IN 5 DEVICES CLOTTED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22998329 ↗MalfunctionAug 13, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED BEFORE USING THE BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES THERE WAS A MISSING TUBE LABEL ON 200 DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22794324 ↗MalfunctionJul 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES THERE WAS ERRONEOUS HBA1C RESULTS ON TWO DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22666188 ↗MalfunctionJun 9, 2025Off-Label Use; Off-Label Use
IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES, ONE DEVICE WAS USED PAST THE EXPIRATION DATE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22167464 ↗MalfunctionApr 1, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES PRESENTED AN ADDITIVE ABNORMALITY. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21739035 ↗MalfunctionMar 3, 2025Leak/Splash; Short Fill; Leak/Splash; Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES, THE TUBE UNDERFILLED WHILE BEING DRAWN FROM THE PATIENTS' PORT. THE NURSE THEN PERFORMED A SYRINGE DRAW WITH A DIFFERENT TRANSPORT DEVICE TO FILL THE TUBE. ONCE THE TUBE WAS FILLED IT EXPLODED ON THE TRAY. NO ADVERSE IMPACT, INJURY, OR EXPOSURE WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21505768 ↗MalfunctionJan 22, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED BEFORE USING THE BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES THERE WAS DISCOLORED ADDITIVE IN AN UNSPECIFIED NUMBER OF DEVICES. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21206864 ↗MalfunctionJan 17, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED BEFORE USING THE BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES THERE WAS DISCOLORED ADDITIVE IN AN UNSPECIFIED NUMBER OF DEVICES. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21184606 ↗MalfunctionDec 11, 2024Short Fill; Short Fill
IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES, SIXTEEN (16) TUBES UNDERFILLED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20905127 ↗MalfunctionSep 30, 2024Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED WHILE USING BD VACUTAINER EDTA (K2) BLOOD COLLECTION TUBES THAT NINETEEN (19) SAMPLES WERE HEMOLYZED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20337407 ↗MalfunctionJun 21, 2024Short Fill; Short Fill
IT WAS REPORTED THAT DURING USE WITH THE BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19580051 ↗MalfunctionJun 18, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES THERE WAS POOR PLASMA SEPARATION AFTER CENTRIFUGATION OF THE SAMPLE. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19560912 ↗MalfunctionMay 9, 2024Clumping in Device or Device Ingredient; Clumping in Device or Device Ingredient
IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES AN UNSPECIFIED NUMBERS OF SAMPLES EXHIBITED ROULEAUX. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19282399 ↗MalfunctionMar 27, 2024Short Fill; Short Fill
IT WAS REPORTED THAT THE BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES WAS UNDERFILLING. THE PATIENTS WERE RECOLLECTED AND THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18987145 ↗MalfunctionFeb 15, 2024Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED WHEN USING BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES THAT THERE WAS MOISTURE INSIDE THE TUBE. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18712018 ↗MalfunctionFeb 14, 2024Device Damaged Prior to Use; Device Contamination with Chemical or Other Material; Device Damaged Prior to Use; Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES THAT THERE WAS FOREIGN MATTER IN THE TUBE AND A CRACKED LID. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18705380 ↗MalfunctionFeb 13, 2024Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES THERE WAS TWO TUBES WITH ABNORMAL ADDITIVE FORM. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18699664 ↗
Other Tubes, vacuum sample, with anticoagulant devices
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- Cyto-Chex BCT 213559Streck, Inc. · Tubes, Vacuum Sample, With Anticoagulant1 recall0 reports
- Vacuette 454332Greiner Bio-One GmbH · Tubes, vacuum sample, with anticoagulant1 recall0 reports
- Cyto-Chex BCT 218980Streck, Inc. · Tubes, Vacuum Sample, With Anticoagulant1 recall0 reports
- Vacuette 454334Greiner Bio-One GmbH · Tubes, vacuum sample, with anticoagulant1 recall0 reports
- BD MiniDraw™ Finger Sleeve, Extra-Large 366616Becton, Dickinson And Company · Tubes, vacuum sample, with anticoagulant25 reports
- BD MiniDraw™ Finger Sleeve, Large 366615Becton, Dickinson And Company · Tubes, vacuum sample, with anticoagulant21 reports
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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