BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes 367859Recalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 30382903678595), received between Dec 5, 2017 and Jan 14, 2026 — classified as 89 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (44 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 89 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2026Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 5.4 MG BLOOD COLLECTION TUBES, FIVE (5) TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24072480 ↗
• MalfunctionJul 28, 2025Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG THERE WAS LOW SAMPLE DRAW VOLUME IN 3 DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636713 ↗
• MalfunctionJun 18, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 5.4 MG BLOOD COLLECTION TUBES, THREE (3) TUBES HAD WRINKLED/LIFTED LABELS WHILE TWO (2) TUBES WERE MISSING A LABEL. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22288251 ↗
• MalfunctionJun 12, 2025Short Fill; Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 5.4 MG BLOOD COLLECTION TUBES, TEN (10) TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22195570 ↗
• MalfunctionFeb 18, 2025Coagulation in Device or Device Ingredient; Difficult to Insert; Coagulation in Device or Device Ingredient; Difficult to Insert

  IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 5.4 MG BLOOD COLLECTION TUBES THERE WAS TUBE PUSH OFF SEEN WITH 10 TUBES, AND CLOTTING IN THE TUBE WAS SEEN IN ANOTHER 10 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21402135 ↗
• MalfunctionFeb 18, 2025Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED AFTER USING BD VACUTAINER® K2 EDTA (K2E) 5.4 MG BLOOD COLLECTION TUBES 10 SAMPLES EXHIBITED CLOTTING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21398422 ↗
• MalfunctionFeb 6, 2025Short Fill; Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 5.4 MG BLOOD COLLECTION TUBES 10 TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21323650 ↗
• MalfunctionJul 19, 2024Short Fill; Short Fill

  IT WAS REPORTED THAT THE BD VACUTAINER® K2 EDTA (K2E) 5.4 MG BLOOD COLLECTION TUBE UNDERFILLED. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19781437 ↗
• MalfunctionFeb 12, 2024Difficult to Insert; Device Contamination with Chemical or Other Material; Difficult to Insert; Device Contamination with Chemical or Other Material

  IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 5.4 MG BLOOD COLLECTION TUBES THAT THERE WAS FOREIGN MATTER AND AN IMPROPERLY SEATED STOPPER. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691665 ↗
• MalfunctionJan 10, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD VACUTAINER® K2 EDTA (K2E) 5.4 MG BLOOD COLLECTION TUBES HAD EMBEDDED FM. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18489646 ↗
• MalfunctionJan 8, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD VACUTAINER® K2 EDTA (K2E) 5.4 MG BLOOD COLLECTION TUBES HAD FOREIGN MATTER. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18463379 ↗
• MalfunctionMar 9, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4 MG BLOOD COLLECTION TUBE THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THIS EVENT AFFECTED 5 TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHITE GRANULES ARE ADHERING TO THE INTERIOR WALL OF TUBES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16510638 ↗
• MalfunctionJul 8, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4 MG BLOOD COLLECTION TUBE THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE IS "SOMETHING LONG PROTRUDING INSIDE TUBE WALL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14959879 ↗
• MalfunctionJun 30, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4 MG BLOOD COLLECTION TUBE THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "SOME LONG PROTRUDE IS INSIDE THE TUBE WALL. THE PROTRUSION SEEMS LIKE TUBE MATERIAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14877209 ↗
• MalfunctionMay 9, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4 MG BLOOD COLLECTION TUBE THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "SOMETHING LONG PROTRUDE INSIDE TUBE WALL. THE PROTRUSION SEEMED LIKE TUBE MATERIAL AND THAT EFFECT THE INSTRUMENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14342065 ↗
• MalfunctionJan 28, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4 MG BLOOD COLLECTION TUBE THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "FOREIGN MATERIAL IS IN THE TUBE CAP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13388017 ↗
• MalfunctionSep 16, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4 MG BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED FOREIGN MATTER IN TUBE BIOLOGICAL AND NON-BIOLOGICAL. THIS EVENT OCCURRED TWICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE FOLLOWING ISSUE WAS FOUND IN TUBE: DIRTY TUBE ×2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12485605 ↗
• MalfunctionAug 30, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4 MG BLOOD COLLECTION TUBE THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE FOLLOWING ISSUE WAS FOUND IN TUBE: FOREIGN MATTER IN TUBE X1."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12386287 ↗
• MalfunctionJul 16, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4 MG BLOOD COLLECTION TUBE THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE FOLLOWING ISSUE WAS FOUND IN TUBE: FOREIGN MATTER IN TUBE X1."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12181126 ↗
• MalfunctionJun 3, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4 MG BLOOD COLLECTION TUBE THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE FOLLOWING ISSUE WAS FOUND IN TUBE: SPOT IN TUBE ×1."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11929917 ↗
• MalfunctionMay 17, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4 MG BLOOD COLLECTION TUBES THERE WAS UNDER-FILL OR LOW DRAW OF THE TUBES WITH BLOOD. THIS EVENT OCCURRED 100 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER AND TRANSLATED TO ENGLISH. THE CUSTOMER STATED: THERE WAS A "VACUUM ISSUE" WITH THE TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11834603 ↗
• MalfunctionApr 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4 MG BLOOD COLLECTION TUBE THERE WAS A BROKEN LID/CAP/HEMOGARD SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE DEVICE HAD A "DAMAGED CAP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11741835 ↗
• MalfunctionApr 6, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THE BD VACUTAINER® K2 EDTA (K2E) BLOOD COLLECTION TUBES EXPERIENCED FOREIGN MATTER IN TUBE; BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. TRANSLATED TO ENGLISH, THE CUSTOMER STATED: "FM IN TUBE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11621151 ↗
• MalfunctionMar 25, 2021Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4 MG BLOOD COLLECTION TUBES THERE WAS UNDER-FILL OR LOW DRAW OF THE TUBES WITH BLOOD. THIS EVENT OCCURRED 20 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER AND TRANSLATED TO ENGLISH. THE CUSTOMER STATED: THERE WAS "VACUUM LOSS IN THIS LOT OF EDTA TUBES." NO FURTHER INFORMATION REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572137 ↗
• MalfunctionMar 25, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4 MG BLOOD COLLECTION TUBES THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT OCCURRED 20 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WAS "VACUUM LOSS AND LOW VOLUME DRAW.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572100 ↗

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, Classified
  a. 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 · Terminated
  BD 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 · Terminated
  BD 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.