BD Vacutainer® K2 EDTA (K2E) 7.2mg Blood Collection Tubes 367844Recalls & reported problems

Summary

The FDA's MAUDE database contains 182 adverse event reports that list this exact device (DI 30382903678441), received between Oct 27, 2017 and Apr 5, 2023 — classified as 182 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (37 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 182 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2023Overfill; Separation Problem; Overfill; Separation Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA K2E 7.2MG BLOOD COLLECTION TUBE THERE WAS OVERFILL AND STOPPER POPS OUT OF THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE STOPPERS OF MATERIAL # 367844 POP OFF ONLY WHEN THERE WERE CLEARLY ERRORS IN SAMPLE ACQUISITION, THERE WAS TOO MUCH BLOOD IN THE TUBES, WHICH PUSHED THE STOPPERS. IT DIDN'T HAPPEN WITH SAMPLES WITH GOOD SAMPLE VOLUME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16686429 ↗
• MalfunctionJan 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE WITH BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES THE STOPPER ARE COMING OFF. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: THE TUBES ARE GETTING OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218629 ↗
• MalfunctionSep 30, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED ABNORMAL ADDITIVE. THIS EVENT OCCURRED ONCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: CUSTOMER RESPONDED STATING THAT NO CALCULATIONS WERE DONE. CUSTOMER REQUESTED FURTHER CLARIFICATION OF ADDITIVE AND CONCENTRATION VALUES PRINTED IN OUR CATALOG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15514043 ↗
• MalfunctionMay 19, 2022Separation Problem; Separation Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBE THE STOPPER PULLED OUT OF THE TUBE WHEN IN THE ANALYZER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE WAS POOR CLOSURE OF THE LID THAT PREVENTS THE PROPER USE OF THE PRODUCT IN THE ANALYZER EQUIPMENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14437994 ↗
• MalfunctionMay 13, 2022Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES IT FAIL TO FILL THE TUBE TO THE INDICATED LINE. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ¿TUBES DO NOT EXHAUST THE VACUUM AND FAIL TO FILL THE TUBE TO THE INDICATED LINE AND EVEN OTHERS, IT LOOKS LIKE THEY HAVE NO VACUUM.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14400686 ↗
• MalfunctionMay 13, 2022Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT OCCURRED 10 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: AT THE MOMENT OF SAMPLE DRAW THE TUBES FILL UNDER THE LIMIT ALLOWED, WHICH IT'S REQUIRED TO ASSURE ACCURATE RESULTS FOR DIAGNOSTIC SUPPORT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14389302 ↗
• MalfunctionJan 13, 2022Overfill; Overfill

  IT HAS BEEN REPORTED THAT THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES HAS BEEN FOUND EXPERIENCING OVERFILL. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: RECENTLY, SEVERAL OF MY CUSTOMERS HAVE FOUND THAT THEIR TUBES (ABOUT 5%) WERE INDEED FILLED WITH A VOLUME GREATER THAN 4ML (I AM TALKING ABOUT A STANDARD SAMPLE AND NOT A FREE FLOW SAMPLE) BY COMPARING THEIR TUBES RECEIVED WITH A STANDARD SOLUTION FILLED TO 4ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13256065 ↗
• MalfunctionDec 30, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBE THE TUBE WAS USED AFTER THE EXPIRATION DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TUBES WERE USED PAST THEIR EXPIRATION DATE. FOR OUR STUDY IN CHILDREN, WE DRAW BLOOD IN K2 EDTA 7.2MG 4.0 ML TUBES (REF (B)(6)), AND RECENTLY REALIZED THAT SOME OF OUR TUBES HAD EXPIRED A FEW MONTHS AGO. IN ORDER TO ACCOUNT FOR ANY DERIVATION IN OUR DATA AND RESULTS. I WANTED TO INQUIRE AS TO WHETHER THE EXPIRATION DATE FOR THE TUBES PERTAINS TO THE VACUUM, THE REAGENT, OR BOTH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13119266 ↗
• MalfunctionOct 28, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT OCCURRED 11 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE "TUBES ARE UNDERFILLING. NO MEDICAL INTERVENTION AS THIS IS FOR A CLINICAL STUDY ONLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712537 ↗
• MalfunctionAug 18, 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) 7.2MG 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 APPEARS TO BE BLOOD OR A RED SUBSTANCE ON THE LID IN THE SEALED FLAT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12339623 ↗
• MalfunctionAug 2, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG 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: "ONE PACK OF ITEM 367844 HAD NO VACUUM IN THE TUBE/NOT DRAWING ANY BLOOD. NO ERRONEOUS RESULTS.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12259804 ↗
• MalfunctionJul 9, 2021Short Fill; Volume Accuracy Problem; Device Contamination with Chemical or Other Material; Short Fill; Volume Accuracy Problem; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED FOREIGN MATTER IN THE TUBE, AS WELL AS UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT THERE ARE SHARK TOOTH LOOKING SHARDS IN THE EDTA TUBES. WHERE THEY¿VE BEEN GETTING SHARK TOOTH LOOKING SHARDS IN THEIR EDTA TUBES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12144501 ↗
• MalfunctionJun 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® EDTA (K2E) 7.2MG BLOOD COLLECTION TUBE THERE WAS STOPPER CREEP OUT OR LOOSE CLOSURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE INTERNAL PLUG IS CRACKING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12096937 ↗
• MalfunctionJun 21, 2021Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED CLOTTING/MICRO CLOTS/FIBRIN CLOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT THERE IS CLUMPING. YES, THE SPECIMEN WAS FILLED TO THE PROPER DRAW VOLUME AND INVERTED 8-10 TIMES. WE HAD BEEN STORING THE TUBES IN THE REFRIGERATOR AFTER DRAWING. WE ARE NO LONGER DOING THAT. THEY STAY AT ROOM TEMP UNTIL TESTING. THE LOT NUMBERS I ORIGINALLY REPORTED WERE ACCIDENTALLY ALL DISPOSED OF. THERE HAS BEEN CLUMPING IN LOT #1014079 LAVENDER EDTA AS WELL. I DO HAVE SOME OF THESE TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12037736 ↗
• MalfunctionJun 4, 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) 7.2MG BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED POOR BARRIER SEPARATION OF THE SAMPLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: CUSTOMER STATED THAT THEY ARE EXPERIENCING PLATELET CLUMPING IN THE LAVENDER AND BLUE TOP TUBES AND THEY AREN'T SURE WHY. THEY HAVE HAD TO REDRAW EVERY PATIENTS BLOOD THAT THE CLUMPING HAS HAPPENED. IT IS THE SAME PERSON COLLECTING THE PATIENTS THAT THERE IS AN ISSUE WITH. SOME WILL HAVE AN ELEVATED WBC AND SLIDES ARE MADE AND THE PLATELET CLUMPS ARE VERIFIED. THESE PATIENTS ARE FROM A PRIMARY CARE PRACTICE. TUBES ARE TRANSPORTED BY COURIER AND ARRIVE SAME DAY USUALLY WITHIN 4-6 HOURS OF COLLECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11940861 ↗
• MalfunctionMay 27, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED BROKEN LID/CAP/HEMOGARD SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "INTERNAL PLUG CRACKING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11898333 ↗
• MalfunctionMay 21, 2021Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES EXPERIENCED CLOTTING/MICRO CLOTS/FIBRIN CLOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: (3 OF 4) WIN: IT WAS REPORTED THERE WAS PLATELET CLUMPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11867342 ↗
• MalfunctionMay 21, 2021Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES EXPERIENCED CLOTTING/MICRO CLOTS/FIBRIN CLOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: (3 OF 4) WIN IT WAS REPORTED THERE WAS PLATELET CLUMPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11867340 ↗
• MalfunctionMay 21, 2021Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED CLOTTING / MICRO CLOTS/FIBRIN CLOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THERE WAS PLATELET CLUMPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11867338 ↗
• MalfunctionMay 21, 2021Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES DEVICE EXPERIENCED CLOTTING/MICRO CLOTS/FIBRIN CLOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "CLOTTING/MICRO CLOTS/FIBRIN CLOTS . PLT CLUMP FLAG."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11866926 ↗
• MalfunctionMay 21, 2021Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED WHEN USING THE BD VACUTAINER K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES DEVICE EXPERIENCED CLOTTING/MICRO CLOTS/FIBRIN CLOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: (4 OF 4) EAS "IT WAS REPORTED THERE WAS PLATELET CLUMPS. PLT CLUMP FLAG".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11866730 ↗
• MalfunctionMay 7, 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) 7.2MG BLOOD COLLECTION TUBES DEVICE EXPERIENCED DISCOLORED / ABNORMAL ADDITIVE FORM. IT WAS REPORTED SMALL PLATELET CLUMPS. "I'VE COLLECTED TUBES FROM 3 LAVENDER TOP TUBES LOT# 0345756 EXP (B)(6) 2022; ISSUE SMALL PLATELET CLUMPS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11791759 ↗
• MalfunctionMay 7, 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) 7.2MG BLOOD COLLECTION TUBES DEVICE EXPERIENCED DISCOLORED / ABNORMAL ADDITIVE FORM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "I'VE COLLECTED TUBES FROM 3 LAVENDER TOP TUBES; ISSUE SMALL PLATELET CLUMPS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11791720 ↗
• MalfunctionMay 7, 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) 7.2MG BLOOD COLLECTION TUBES DEVICE EXPERIENCED DISCOLORED / ABNORMAL ADDITIVE FORM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED SMALL PLATELET CLUMPS. "I'VE COLLECTED TUBES FROM 3 LAVENDER TOP TUBES LOT# 0345756 EXP 4/30/22; ISSUE SMALL PLATELET CLUMPS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11791546 ↗
• MalfunctionMar 11, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) BLOOD COLLECTION TUBES THERE WAS STOPPER POPS OUT OF THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "TUBE CAP CAME OFF WHEN SAMPLE WAS TAKEN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11467039 ↗

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.