BD Vacutainer® Trace Element K2 EDTA (K2E) 10.8mg Blood Collection Tubes 368381Recalls & reported problems
Becton, Dickinson And Company · TUBE TRCE PLH 13X100 6.0 UPLBL R/BL EDTA · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Vacutainer Trace Element K2 EDTA tube is a blood collection tube used for trace element testing. The 68 reports mostly describe leaking or splashing, tubes deforming, blood clotting inside the tube, contamination or brownish foreign matter in the tube, and low fill volume from low vacuum, along with some inaccurate or imprecise test results. No deaths and no injuries were reported, and most reports note no impact on the patient. 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
- 91
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 30382903683810), received between Dec 1, 2017 and Sep 14, 2026 — classified as 91 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (31 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
- Incorrect, Inadequate or Imprecise Result or Readings31
- Leak/Splash18
- Material Deformation12
- Coagulation in Device or Device Ingredient10
- Incorrect Or Inadequate Test Results10
- Device Contamination with Chemical or Other Material9
- Device Markings/Labelling Problem4
- Short Fill4
Patient problems
- No Clinical Signs, Symptoms or Conditions45
- No Known Impact Or Consequence To Patient33
- No Consequences Or Impact To Patient5
- No Information5
- No Patient Involvement3
Recent adverse event reports
The 25 most recent of 91 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50756466 ↗MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735928 ↗MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735924 ↗MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735923 ↗MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735922 ↗MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735921 ↗MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings
Report 4 of 20.It was reported that after using BD Vacutainer® Trace Element K2 EDTA (K2E) 10.8mg Blood Collection Tubes, an unspecified number of tubes from one patient exhibited elevated molybdenum results during in-house ICPMS testing. The patient was contacted for sample recollection. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735920 ↗MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735919 ↗MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735915 ↗MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735914 ↗MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735910 ↗MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735909 ↗MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735908 ↗MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735907 ↗MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735906 ↗MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings
Report 17 of 20It was reported that after using BD Vacutainer® Trace Element K2 EDTA (K2E) 10.8mg Blood Collection Tubes, an unspecified number of tubes from one patient exhibited elevated molybdenum results during in-house ICPMS testing. The patient was contacted for sample recollection. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735905 ↗MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735904 ↗MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735903 ↗MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735902 ↗MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735899 ↗MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings
Report 1 of 20It was reported that after using BD Vacutainer® Trace Element K2 EDTA (K2E) 10.8mg Blood Collection Tubes, an unspecified number of tubes from one patient exhibited elevated molybdenum results during in-house ICPMS testing. The patient was contacted for sample recollection. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735883 ↗MalfunctionSep 10, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50716223 ↗MalfunctionAug 4, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50129500 ↗MalfunctionJul 29, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50075086 ↗MalfunctionJul 29, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50075081 ↗
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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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