BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes 367835Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 30382903678359), received between Apr 13, 2018 and Sep 22, 2022 — classified as 63 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (21 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 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2022Leak/Splash; Separation Problem; Leak/Splash; Separation Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED STOPPER POP OFF AND LEAKAGE. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THEY LAID THE TUBE OF BLOOD ON THE COUNTER AND IT EXPLODED. IN ANOTHER INCIDENT THE TUBE WAS LEAKING DURING A BLOOD DRAW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15462820 ↗
• MalfunctionAug 31, 2022Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT OCCURRED 60 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: TUBES ARE PRESENTING VACUUM FAILURE. THE TUBE FILLS ONLY 1 TO 2 ML, WHEN IT SHOULD HAS FILLED 3ML, AND DOES NOT ACCOMPLISHES WITH ADDITIVE/BLOOD RATIO. BDREP INTERNAL COMMENTS: IT MAY COMPROMISE THE ACCURACY OF RESULTS, AND AFFECTING THE DIAGNOSIS. ADDITIONAL INFORMATION RECEIVED FROM THE CLIENT ON 18.AUG.2022: HOW MANY UNITS OF THE PRODUCT PRESENTED THE REPORTED DEVIATION? (AMOUNT AFFECTED); A: OF EACH BOX OF 100, 60 WERE FAULTY. WERE THERE ANY INACCURATE OR ERRONEOUS TEST RESULTS? IF YES, WHICH ONES? (DETAIL) A: THE COLLECTORS IDENTIFIED DEFECTIVE WERE NOT PROCESSED THANKS TO OUR BARRIERS, BUT THE RISK WAS CONSOLIDATED BY REQUIRING A NEW SAMPLE TO BE TAKEN. IF YES, HAVE ERRONEOUS RESULTS BEEN RELEASED TO PATIENTS/HEALTHCARE PROFESSIONALS? A: THE COLLECTORS IDENTIFIED DEFECTIVE WERE NOT PROCESSED THANKS TO OUR BARRIERS, BUT THE RISK WAS CONSOLIDATED BY REQUIRING A NEW SAMPLE TO BE TAKEN. IF YES, HAS THERE BEEN A C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331913 ↗
• MalfunctionAug 31, 2022Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT OCCURRED 60 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: TUBES ARE PRESENTING VACUUM FAILURE. THE TUBE FILLS ONLY 1 TO 2 ML, WHEN IT SHOULD HAS FILLED 3ML, AND DOES NOT ACCOMPLISHES WITH ADDITIVE/BLOOD RATIO. HOW MANY UNITS OF THE PRODUCT PRESENTED THE REPORTED DEVIATION? (AMOUNT AFFECTED);OF EACH BOX OF 100, 60 WERE FAULTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331874 ↗
• MalfunctionJun 9, 2022Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: TUBES HAVE VACUUM DEFICIENCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14646908 ↗
• MalfunctionJun 9, 2022Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT OCCURRED TWO TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: TUBES HAVE VACUUM DEFICIENCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14646849 ↗
• MalfunctionJun 9, 2022Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBE, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT OCCURRED TWO TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: TUBES HAVE VACUUM DEFICIENCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14646061 ↗
• MalfunctionMar 18, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, THE USER IDENTIFIED USING THE TUBE AFTER EXPIRATION DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT CUSTOMER ORDERED VACUTAINER TUBES THROUGH MCKESSON AND WHEN THEY RECEIVED THEM THEY WERE EXPIRED. CUSTOMER CAN NOT CONFIRM SPECIFIC DATE OF RECEIPT OR EVENT, 3 CASES WERE RECEIVED. EXPIRED VACUTAINER TUBES WERE PUT INTO USE AND CUSTOMER IS INQUIRING WHAT THE IMPACT IS TO THE SPECIMEN AFTER USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13810407 ↗
• MalfunctionJan 28, 2022Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED COAGULATED/CLOGGED TUBES. THIS EVENT OCCURRED TWO TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: FOR MORE THAN 1 MONTH CUSTOMER HAS OBSERVED THAT BOTH HEMATOLOGY COUNTERS AND COAGULOMETERS THAT PIERCE THE RUBBER FROM STOPPERS OF TUBES CONTAINING THE SAMPLES TO BE ANALYZED, INSTEAD OF GOING THROUGH THEM, IN SOME CASES PRODUCE A PUNCHING EFFECT (CORING). IT CAUSES THE CLOGGING OF PIERCING NEEDLES AND THE SAMPLING NEEDLES AS WELL, CAUSING THE IMMEDIATE STOPPAGE OF THE EQUIPMENT AND THE CONTINUOUS CALL FOR TECHNICAL SERVICE, SO AS WELL CAUSES A DELAY CAUSED BY SOLVING THIS PROBLEM. THE EVENT FREQUENCY IS RANDOMLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13388817 ↗
• MalfunctionNov 19, 2021Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12845347 ↗
• MalfunctionNov 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBE THERE WAS STOPPER CREEP OUT OR LOOSE CLOSURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "AFTER BLOOD COLLECTION, THERE WAS STOPPER CREEPOUT. THIS OCCURRED WHEN THE BLOOD WAS BEING MIXED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12771015 ↗
• MalfunctionOct 22, 2021Unexpected Color; Unexpected Color

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED A DIFFERENT COLOR/SHADE. THIS EVENT OCCURRED 100 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: INCORRECT COLOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12682627 ↗
• MalfunctionSep 24, 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) 5.4MG BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED FOREIGN MATTER IN TUBE; BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: FM ON TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12530506 ↗
• MalfunctionAug 19, 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) 5.4MG BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED FOREIGN MATTER IN TUBE; BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: CUSTOMER FOUND FM IN TUBE AFTER USE(DURING MIXING).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12345268 ↗
• MalfunctionAug 16, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  TUBE DOESN'T FILL PROPERLY. INFORMATION RECEIVED ON 08/10/2021: THERE WAS NO DAMAGE. NO INCONSISTENT RESULTS RELATED TO THE FAILURE HAVE BEEN RELEASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12328245 ↗
• MalfunctionAug 2, 2021Incorrect, Inadequate or Imprecise Result or Readings; Device Contamination with Chemical or Other Material; Incorrect, Inadequate or Imprecise Result or Readings; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBE THERE WAS DISCOLORED/ABNORMAL ADDITIVE FORM AND FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE "ADDITIVE WAS NOT SPRAYED PROPERLY. STOPPER CONTAMINATED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12259806 ↗
• MalfunctionJul 21, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE IS A CLINIC SITE THAT ARE HAVING ISSUES MAINTAINING VACUUM OF THE EDTA VACUTAINER TUBES. THIS ISSUE HAS EXPANDED TO SEVERAL KITS. THE TECHNICIANS HAVE TRIED TO RESOLVE THIS ISSUE BY CHANGING TECHNICIANS AND ALTERNATING BETWEEN STRAIGHT AND BUTTERFLY NEEDLES BUT STILL THE ISSUE REMAINS. THE OTHER VACUTAINER TUBES IS NO ISSUE THIS IS JUST WITH EDTA TUBES. THE NEEDLES ARE NOT PROVIDED BY ACM AND THEY ARE SENT SEPARATELY FROM THE TUBES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12204364 ↗
• 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) 5.4MG 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 WAS "FOREIGN MATTER IN THE TUBE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12181010 ↗
• MalfunctionJul 13, 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) 5.4MG BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED FOREIGN MATTER IN THE TUBE (STOPPER). THIS EVENT OCCURRED ONE HUNDRED TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: FM ON STOPPER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12163345 ↗
• MalfunctionJul 7, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "TUBES ARE NOT DRAWING PROPERLY. THE NURSE STAFF REPORTED UNDERFILL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12128215 ↗
• MalfunctionJun 3, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBE THE SHIELD/CAP STOPPER IS A DIFFERENT COLOR/SHADE OR FADED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER AND TRANSLATED TO ENGLISH. THE CUSTOMER STATED: THERE IS A "DIFFERENT CAP COLOUR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11930028 ↗
• MalfunctionApr 1, 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) 5.4MG BLOOD COLLECTION TUBES THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THIS EVENT OCCURRED 5 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WAS A "STAIN ON THE HEAD COVER." NO FURTHER INFORMATION REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11603545 ↗
• MalfunctionMar 24, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES THERE WAS UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED: K2EDTA LILAC CAP TUBE VACUUM FAILURES FROM CATALOG 367835. THE SITUATION HAPPENS DURING USE. ON (B)(6) 2021: ADDITIONAL INFORMATION RECEIVED. WE RECEIVED 1000 TUBES. WE DISTRIBUTED TO THE SERVICES AND TOOK THEM OUT TO USE IN TAKING SAMPLES FROM THE LABORATORY AND WE OBSERVED THAT THEY WERE FILLING UP TO 0.5 ML LESS UNDER VACUUM, ON THE FLOORS AS THEY SOMETIMES TAKE WITH A SYRINGE OR CATHETER IT WAS EXPLAINED HOW MUCH THEY SHOULD FILL THEM. WE ASSOCIATE THAT AS WE ARE LOCATED IN A MUNICIPALITY WHERE THE HEIGHT IS HIGH, THE PRESSURE OF THE TUBES MUST BE FOR HIGH ALTITUDE. WE INFORM AND WE ONLY HAVE 4 PACKAGES OF 100 TUBES (400 TUBES) THAT HAVE NOT BEEN USED AND WOULD BE THE ONES THAT WOULD HAVE TO BE GIVEN THE CREDIT NOTE. HOW MANY UNITS (TUBES) AFFECTED? 1000 TUBES. WHAT IS THE FREQUENCY OR OCCURRENCE RATE (1 DAY, % OF TUBES AFFECTED, PATIENTS INVOLVED, HOW MANY TEST PER DAY ETC.) ALL TUBES THAT WERE USED. WHAT IS THE LABELED DRAW VOLUM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11566199 ↗
• MalfunctionDec 4, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO USE WITH BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES FOREIGN MATTER WAS DISCOVERED IN TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DARK TUBE.

  Patient problems: No Patient Involvement

  MAUDE report 10945030 ↗
• MalfunctionNov 3, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO USE WITH A BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES FOREIGN MATTER WAS DISCOVERED IN 2 TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FM IN EDTA TUBE.

  Patient problems: No Patient Involvement

  MAUDE report 10782190 ↗
• MalfunctionSep 21, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CAPS ARE LOOSE PRIOR TO USE WITH 100 BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CAP LOOSE.

  Patient problems: No Patient Involvement

  MAUDE report 10560903 ↗

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.