BD Vacutainer® K2 EDTA (K2E) 10.8mg Blood Collection Tubes 367863Recalls & reported problems
Becton, Dickinson And Company · TUBE K2EDTA PLH 13X100 6.0 PLBL LAV · Class 2
All models of BD Vacutainer K2 EDTA (K2E) 10.8mg 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 appears in 268 adverse event reports, with no deaths and 1 injury. The reports mostly describe tubes containing foreign matter or particles, small holes causing leaks, underfilling and clotting, and most state that no adverse impact on patients or users was reported. Reports fell to 8 in the last 12 months from 28 in the year before. 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
- 268
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 268 adverse event reports that list this exact device (DI 30382903678632), received between Dec 4, 2017 and Jun 11, 2026 — classified as 1 injury, 267 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (88 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
- Device Contamination with Chemical or Other Material88
- Leak/Splash37
- Short Fill35
- Incorrect Or Inadequate Test Results21
- Incorrect, Inadequate or Imprecise Result or Readings19
- Device Markings/Labelling Problem18
- Device Ingredient or Reagent Problem16
- Volume Accuracy Problem12
Patient problems
- No Clinical Signs, Symptoms or Conditions107
- No Known Impact Or Consequence To Patient103
- No Patient Involvement34
- No Consequences Or Impact To Patient17
- No Information7
- Exposure to Body Fluids1
- Hemolysis1
Recent adverse event reports
The 25 most recent of 268 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2026Coagulation in Device or Device Ingredient
IT WAS REPORTED THAT DURING THE USE OF BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBE, ONE (1) TUBE APPEARED TO BE CLOTTED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENTS OR USERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25476957 ↗MalfunctionJun 10, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BEFORE THE USE OF THE BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES, ONE (1) TUBE WAS FOUND TO CONTAIN GREEN PARTICLE INSIDE THE TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25453102 ↗MalfunctionMay 26, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES, SIX TUBES HAVE SMALL HOLES IN THEM RESULTING IN SAMPLE LEAKAGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25285251 ↗MalfunctionMay 12, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES CONTAINED FOREIGN MATTER. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25153515 ↗MalfunctionApr 30, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 10.8MG 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 25052782 ↗MalfunctionMar 3, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 10.8MG 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 24503557 ↗MalfunctionFeb 9, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES, FOREIGN MATTER WAS FOUND EMBEDDED IN 51 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24299194 ↗MalfunctionDec 4, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES, FOREIGN MATTER WAS FOUND IN TWO (2) TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23723065 ↗MalfunctionOct 30, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES, FOREIGN MATTER- HAIR 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 23425903 ↗MalfunctionOct 28, 2025Excessive Heating; Excessive Heating
IT WAS REPORTED THAT PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES EXHIBITED TEMPERATURE EXCURSION DURING TRANSPORT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23410093 ↗MalfunctionOct 28, 2025Excessive Heating; Excessive Heating
IT WAS REPORTED THAT PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES EXHIBITED TEMPERATURE EXCURSION DURING TRANSPORT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23410091 ↗MalfunctionSep 16, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 10.8MG 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 23069456 ↗MalfunctionSep 15, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES, FOREIGN MATTER WAS FOUND IN TWO (2) TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23052936 ↗MalfunctionSep 4, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BEFORE USING ONE (1) BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES, THE CAP OF THE TUBE WAS CRACKED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22967659 ↗MalfunctionJul 28, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES, THERE WERE EIGHT (8) HEMOGARDS WITH A BURR ON THE CAP. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22630577 ↗MalfunctionJul 28, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES, THERE WAS ONE (1) HEMOGARD CAP WITH A BURR ON THE CAP. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22629396 ↗MalfunctionJul 24, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES, THERE WERE 100 TUBES WITH A BURR ON THE HEMOGARD CAP. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22588505 ↗MalfunctionJul 24, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES, THERE WERE TEN (10) STOPPERS WITH A BURR ON THE HEMOGARD CAP. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22588472 ↗MalfunctionJun 26, 2025Short Fill; Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 10.8MG 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 22339068 ↗MalfunctionJun 26, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES, THERE WERE 50 HEMOGARD CLOSURES WITH A SHARP BURR ON THEM. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22338367 ↗MalfunctionMay 22, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES CONTAINED FOREIGN MATTER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22073567 ↗MalfunctionMay 1, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES, FOREIGN MATTER WAS FOUND IN 6 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21944895 ↗MalfunctionApr 25, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES, THERE WAS 1 TUBE WITH AN ADDITIVE ABNORMALITY. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21913665 ↗MalfunctionApr 25, 2025Short Fill; Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES, THERE WERE 2 TUBES THAT UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21912727 ↗MalfunctionApr 24, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES, THERE WAS 1 TUBE WITH AN ADDITIVE ABNORMALITY. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21899834 ↗
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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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