BD Vacutainer® K2 EDTA (K2E) Blood Collection Tubes 367862Recalls & reported problems

Summary

The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI 30382903678625), received between Oct 30, 2017 and Sep 28, 2026 — classified as 111 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (38 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 111 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Fluid/Blood Leak

  It was reported that when using the BD Vacutainer® K2 EDTA (K2E) Plus Blood Collection Tubes, the stopper came out of an unspecified number of tubes, resulting in blood spillage. No adverse impact was reported regarding the patient or user.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917198 ↗
• MalfunctionMay 13, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) BLOOD COLLECTION TUBES, FOREIGN MATTER WAS OBSERVED IN AN UNSPECIFIED NUMBER OF TUBES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164074 ↗
• MalfunctionSep 4, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BEFORE USING ONE (1) BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES, THE CAP WAS DEFORMED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22964578 ↗
• MalfunctionJul 29, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES, THERE WERE THREE (3) HEMOGARD CAPS WITH A BURR ON THEM. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22644238 ↗
• MalfunctionJun 27, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  BD RECEIVED ONE PHOTO FOR INVESTIGATION. A VISUAL EXAMINATION OF THE PHOTO REVEALED A GATE STUB ON THE HEMOGARD CLOSURE, WITH A PIECE OF PLASTIC PROTRUDING FROM THE GATE. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: MOLDING DEFECT. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22347658 ↗
• MalfunctionJun 27, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES, THERE WERE 20 HEMOGARD CLOSURES WITH A SHARP BURR ON THE CAP. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22347229 ↗
• MalfunctionJun 27, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES, THERE WERE UNSPECIFIED NUMBER OF HEMOGARD CLOSURES WITH A SHARP BURR ON THE CAP. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345773 ↗
• MalfunctionJun 27, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES, THERE WERE 3000 HEMOGARD CLOSURES WITH A SHARP BURR ON THE CAP. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345761 ↗
• MalfunctionJun 26, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES, THERE WERE AN UNSPECIFIED NUMBER OF CLOSURES WITH A SHARP PROTRUDING BURR. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22342259 ↗
• MalfunctionMay 30, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES, THERE WERE AN UNSPECIFIED NUMBER OF CLOSURE SHIELDS WITH A SHARP PROTRUSION MOLDING DEFECT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114803 ↗
• MalfunctionMay 7, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED DURING USE OF BD VACUTAINER® K2 EDTA (K2E) BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF CAPS HAVE BURRS THAT INTERFERE WITH THE TUBE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21980663 ↗
• MalfunctionFeb 6, 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) PLUS BLOOD COLLECTION TUBES FOREIGN MATTER WAS SEEN IN 1 TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21327729 ↗
• MalfunctionJul 2, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES HAVE HAD MULTIPLE INSTANCES OF TUBE PUSH OFF. THERE HAS BEEN NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19654713 ↗
• MalfunctionMay 15, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT PRIOR TO USING A BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBE, THE HEMOGARD SHIELD WAS CRACKED. NO IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19327169 ↗
• MalfunctionMay 13, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES, BLACK PARTICLES WERE FOUND IN THE TUBES. NO IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19305935 ↗
• MalfunctionFeb 8, 2024Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBE, THERE WAS A LOW DRAW OF A TUBE WITH BLOOD. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18667447 ↗
• MalfunctionJan 26, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES THERE WAS DAMAGE TO THE CAP. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18586261 ↗
• MalfunctionJan 5, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18459566 ↗
• MalfunctionJan 5, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES HAD A BLACK DOT. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18458857 ↗
• MalfunctionDec 29, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT THE BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES UNDERFILLED 4 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18419562 ↗
• MalfunctionDec 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES HAD A LOOSE CLOSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18369207 ↗
• MalfunctionDec 11, 2023Premature Separation; Premature Separation

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES AFTER OPENING THE COVER AND CLOSING IT AGAIN, THE COVER WILL COME LOOSE. THIS EVENT OCCURRED 6000 TIMES. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18306329 ↗
• MalfunctionNov 27, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT HAS BEEN REPORTED THAT THE BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBE HAS BEEN USED AFTER THE EXPIRATION DATE. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING TUBE WAS USED ONE WEEK PAST EXPIRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209979 ↗
• MalfunctionNov 21, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES THERE WAS POOR SUCTION AND THE TUBE WAS UNDERFILLED. THIS ISSUE OCCURRED TWICE. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18185585 ↗
• MalfunctionOct 11, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BEFORE USING TWO BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES FOREIGN MATTER WAS FOUND. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS FOUND TWO UNUSED TUBES IN THE SAME BOX AND BATCH THAT HAS THIS SAME ISSUE, THESE TWO TUBES CAN BE SENT IN SINCE THEY ARE NOT CONTAMINATED. PLEASE BOOK A PICK UP FOR THESE TWO TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17915129 ↗

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.