BD Vacutainer® K2E (EDTA) 7.2mg 368861Recalls & reported problems
Becton, Dickinson U.K. Limited · BD Vacutainer® K2E (EDTA) 7.2mg · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Vacutainer K2E blood collection tube has 326 reports: 325 malfunctions and 1 injury, with no deaths. Many describe tubes that are underfilled, with others mentioning leaks, splashes and contamination. No recalls name this device. Reports fell to 15 in the last 12 months from 36 in the 12 months before.
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
- 327
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 327 adverse event reports that list this exact device (DI 30382903688617), received between Nov 30, 2017 and Sep 10, 2026 — classified as 1 injury, 326 malfunctions.
The most frequently reported specific device problem is “Short Fill” (82 reports).
3 other recalls cover devices cleared under the same FDA submission (BK050036); 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
Most reported problems
Device problems
- Short Fill82
- Device Contamination with Chemical or Other Material50
- Leak/Splash47
- Volume Accuracy Problem43
- Material Deformation38
- Incorrect, Inadequate or Imprecise Result or Readings26
- Incorrect Or Inadequate Test Results18
- Device Ingredient or Reagent Problem16
Patient problems
- No Clinical Signs, Symptoms or Conditions162
- No Known Impact Or Consequence To Patient124
- No Consequences Or Impact To Patient26
- No Information8
- No Patient Involvement7
- Exposure to Body Fluids1
Recent adverse event reports
The 25 most recent of 327 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Separation Problem
It was reported that during blood collection using BD Vacutainer® K2E (EDTA) (b)(6) Plus Blood Collection Tubes, the cap of one tube opened. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50714842 ↗MalfunctionMay 27, 2026Short Fill
REPORT 9 OF 10: IT WAS REPORTED THAT DURING BLOOD DRAW OF ONE PATIENT USING BD VACUTAINER® K2E (EDTA) 7.2MG PLUS 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 25302130 ↗MalfunctionMay 27, 2026Short Fill
REPORT 7 OF 10: IT WAS REPORTED THAT DURING BLOOD DRAW OF ONE PATIENT USING BD VACUTAINER® K2E (EDTA) 7.2MG PLUS 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 25301842 ↗MalfunctionMay 27, 2026Short Fill
REPORT 5 OF 10: IT WAS REPORTED THAT DURING BLOOD DRAW OF ONE PATIENT USING BD VACUTAINER® K2E (EDTA) 7.2MG PLUS 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 25301817 ↗MalfunctionMay 27, 2026Short Fill
REPORT 10 OF 10: IT WAS REPORTED THAT DURING BLOOD DRAW OF ONE PATIENT USING BD VACUTAINER® K2E (EDTA) 7.2MG PLUS 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 25301790 ↗MalfunctionMay 27, 2026Short Fill
REPORT 6 OF 10: IT WAS REPORTED THAT DURING BLOOD DRAW OF ONE PATIENT USING BD VACUTAINER® K2E (EDTA) 7.2MG PLUS 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 25301787 ↗MalfunctionMay 27, 2026Short Fill
REPORT 3 OF 10: IT WAS REPORTED THAT DURING BLOOD DRAW OF ONE PATIENT USING BD VACUTAINER® K2E (EDTA) 7.2MG PLUS 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 25301785 ↗MalfunctionMay 27, 2026Short Fill
REPORT 4 OF 10: IT WAS REPORTED THAT DURING BLOOD DRAW OF ONE PATIENT USING BD VACUTAINER® K2E (EDTA) 7.2MG PLUS 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 25301783 ↗MalfunctionMay 27, 2026Short Fill
REPORT 8 OF 10. IT WAS REPORTED THAT DURING BLOOD DRAW OF ONE PATIENT USING BD VACUTAINER® K2E (EDTA) 7.2MG PLUS 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 25301780 ↗MalfunctionMay 27, 2026Short Fill
REPORT 2 OF 10. IT WAS REPORTED THAT DURING BLOOD DRAW OF ONE PATIENT USING BD VACUTAINER® K2E (EDTA) 7.2MG PLUS 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 25301779 ↗MalfunctionMay 27, 2026Short Fill
REPORT 1 OF 10: IT WAS REPORTED THAT DURING BLOOD DRAW OF ONE PATIENT USING BD VACUTAINER® K2E (EDTA) 7.2MG PLUS 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 25301768 ↗MalfunctionApr 28, 2026Improper Chemical Reaction
IT WAS REPORTED THAT AFTER USING BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES ARE COAGULATED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25018424 ↗MalfunctionJan 20, 2026Material Protrusion/Extrusion
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® K2E (EDTA) 7.2MG, AN UNSPECIFIED NUMBER OF TUBES EXHIBITED A PLASTIC PIECE ON THE INNER WALL OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24117636 ↗MalfunctionJan 12, 2026Short Fill
REPORT 1 OF 2. IT WAS REPORTED WHILE USING BD VACUTAINER® K2E (EDTA) 7.2MG PLUS 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 24050062 ↗MalfunctionJan 12, 2026Short Fill
REPORT 1 OF 2. IT WAS REPORTED WHILE USING BD VACUTAINER® K2E (EDTA) 7.2MG PLUS 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 24050035 ↗MalfunctionDec 16, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES, FOREIGN MATTER WAS FOUND 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 23823410 ↗MalfunctionOct 27, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED AFTER USING BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES, THERE WAS BLOOD LEAKING FROM THE STOPPER IN 2 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23398649 ↗MalfunctionSep 17, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED WHILE USING BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES, THERE WAS ONE (1) TUBE WITH A PLASTIC PROTRUSION INSIDE THE TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23073901 ↗MalfunctionAug 19, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED WHILE USING BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES, THE STOPPER ON AN UNSPECIFIED NUMBER OF TUBES WAS UNABLE TO BE PIERCED BY THE ANALYZER FOR SAMPLE ASPIRATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22846341 ↗MalfunctionAug 19, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED WHILE USING BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES, THE STOPPER ON AN UNSPECIFIED NUMBER OF TUBES WAS UNABLE TO BE PIERCED BY THE ANALYZER FOR SAMPLE ASPIRATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22846337 ↗MalfunctionAug 19, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2E (EDTA) 7.2MG PLUS 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 22845634 ↗MalfunctionAug 19, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD VACUTAINER® K2E (EDTA) 7.2MG PLUS 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 22845614 ↗MalfunctionAug 7, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED AFTER USING BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES, THERE WAS ONE (1) TUBE WITH A SHARP PROTRUSION INSIDE THE TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22743020 ↗MalfunctionAug 7, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED AFTER USING BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES, THERE WAS ONE (1) TUBE WITH A SHARP PROTRUSION INSIDE THE TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22742890 ↗MalfunctionJul 29, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES, THERE WERE 500 TUBES WITH DISCOLORED ADDITIVE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22644619 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under BK050036. One submission often covers many models, so check the product and lot details in each record.
- Z-1618-2022 · May 25, 2022 · Open, Classifieda. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP GLD 3.5ML PLAS VACUTAINER (100/BX), Model Number: 367983. b. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/
- Z-0968-2018 · Aug 29, 2017 · TerminatedBD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determinations, immunohematology testing an
- Z-2434-2015 · Jun 23, 2015 · TerminatedBD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. Provides a means of collecting, transporting, separating, and processing blood in a closed tube.
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- BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes 367856Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1,010 reports
- BD Vacutainer® PST™ Gel and Lithium HeparinN 56 Units 367960Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1 recall747 reports
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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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