BD Vacutainer® K2 EDTA (K2E) 10.8mg Blood Collection Tubes 367899Recalls & reported problems

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 30382903678991), received between Dec 4, 2017 and Jan 28, 2026 — classified as 2 injuries, 90 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (29 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 92 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES WERE USED AFTER THE EXPIRATION DATE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203743 ↗
• MalfunctionSep 5, 2025Excessive Heating; Excessive Heating

  IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES WERE STORED AT INCORRECT TEMPERATURE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22977606 ↗
• MalfunctionOct 23, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES EXHIBIT DISCOLORATION AND RESIDUE. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES TUBES EXHIBIT DISCOLORATION AND RESIDUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17991313 ↗
• MalfunctionSep 28, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT DURING USE WITH BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES HEMOLYSIS OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES INCREASED HEMOLYSIS IN THIS TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17839756 ↗
• MalfunctionMay 8, 2023Separation Problem; Separation Problem

  IT WAS REPORTED THAT DURING DECAPPING WITH BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES THE RUBBER STOPPER REMAINED IN TUBE. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT THE AUTOMATION LINE REMOVES THE PINK PLASTIC PART OF THE CAP BUT NOT THE GRAY STOPPER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16892349 ↗
• MalfunctionMay 2, 2023Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 10.8MG 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: "ONE TUBE OUT OF 100 FROM A BOX OF EDTA TUBES CATALOG 367899 ,LOT# 2132110 APPEARED TO HAVE A SPLASH OF BLOOD IN IT AT THE BOTTOM OF THE TUBE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16854142 ↗
• MalfunctionApr 2, 2023Device 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) 10.8MG BLOOD COLLECTION TUBES "BLACK" FOREIGN MATTER WAS DISCOVERED ON CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES PRODUCT HAS BLACK DEBRIS/CONTAMINATION ON THE CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16661105 ↗
• MalfunctionMar 29, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBE THE STOPPER WAS DIFFICULT TO REMOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: TUBES ARE NOT PROPERLY DECAPPING ON AUTOMATED LINE LEAVING THE GRAY STOPPER IN THE TUBE. THIS CAUSES DOWNSTREAM AFFECTS WHEN THE TUBE IS THEN SENT TO THE OTHER MODULES ON OUR TRACK SYSTEM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639432 ↗
• MalfunctionMar 22, 2023Separation Failure; Separation Failure

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBE THE RUBBER STOPPER REMAINED IN TUBE (STOPPER/SHIELD SEPARATION). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE STOPPER IS NOT BEING REMOVED BY THE ANALYZER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16590436 ↗
• MalfunctionMar 14, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBE THE RUBBER STOPPER REMAINED IN TUBE (STOPPER/SHIELD SEPARATION). THIS EVENT OCCURRED 27 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE IS AN ONGOING ISSUE WITH STOPPER NOT BEING FULLY REMOVED FROM BD VACUTAINER TUBES, IN THIS CASE IT IS FOR CAT 367899 LOT 2166071."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16542235 ↗
• MalfunctionJan 20, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBE THE STOPPER WAS DIFFICULT TO REMOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE RUBBER STOPPER INSIDE THE CAP IS NOT BEING REMOVED WHEN THE CAP IS REMOVED BY THE AUTOMATION. THE COLORED PLASTIC ON THE ONSIDE COMES OFF SO THE AUTOMATION THINKS THE CAP HAS BEEN REMOVED AND CONTINUES TO PROCESS THE SAMPLE. WITH THE RUBBER STILL ON THE TUBE IT THEN CAUSES A PROBE CRASH WHEN THE SAMPLE GETS TO THE TESTING ANALYZER.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218444 ↗
• MalfunctionJan 19, 2023Separation Failure; Separation Failure

  IT WAS REPORTED THAT DURING USE WITH BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES THE AUTOMATION LINE WAS UNABLE TO BE REMOVED. THIS CAUSES A PROBE CRASH WHEN THE SAMPLE GETS TO THE TESTING ANALYZER. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD VACUTAINER® EDTA TUBES (SKU:367899) 6.0ML PINK TOP TUBES ARE CAUSING A PROBLEM WITH THE DXA AUTOMATION LINE. THE RUBBER STOPPER INSIDE THE CAP IS NOT BEING REMOVED WHEN THE CAP IS REMOVED BY THE AUTOMATION. THE COLORED PLASTIC ON THE ONSIDE COMES OFF SO THE AUTOMATION THINKS THE CAP HAS BEEN REMOVED AND CONTINUES TO PROCESS THE SAMPLE. WITH THE RUBBER STILL ON THE TUBE IT THEN CAUSES A PROBE CRASH WHEN THE SAMPLE GETS TO THE TESTING ANALYZER. LOT #1288714.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16200729 ↗
• MalfunctionJan 9, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBE THE RUBBER STOPPER REMAINED IN TUBE (STOPPER/SHIELD SEPARATION). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE RUBBER STOPPER REMAINS IN THE TUBE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16126895 ↗
• MalfunctionJan 5, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBE THE RUBBER STOPPER REMAINED IN TUBE (STOPPER/SHIELD SEPARATION). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE IS AN "ISSUE WITH THE STOPPER WAS NOT FULLY REMOVED FROM BD VACUTAINER TUBES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16108895 ↗
• MalfunctionNov 9, 2022Material Separation; Material Separation

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBE THERE WAS RUBBER STOPPER REMAINED IN TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE RUBBER STOPPER REMAINS IN THE TUBE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15760243 ↗
• MalfunctionSep 12, 2022Break; Defective Component; Break; Defective Component

  IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES ARE EXPLODING AND THE TOPS ARE CROOKED. THE ISSUE OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: CUSTOMER IS REPORTING TUBES EXPLODING ON PRODUCT 367899, LOT 2048419. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER IS REPORTING MULTIPLE TUBES EXPLODE IN THE TUBE SYSTEM, AND BIRTH CENTER HAD ONE EXPLODE WHILE DRAWING IT IN THE PATIENT'S ROOM. CUSTOMER STATED THAT UPON FURTHER EXAMINATION OF THE TUBES, THEY FOUND THAT THE CAPS ARE CROOKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15403171 ↗
• MalfunctionMay 18, 2022Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OR A TUBE WITH BLOOD. THIS EVENT OCCURRED 8 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT TUBES WERE ONLY FILLING TO 2ML THUS RESULTING IN UNDERFILLING. KRIZ REPORTED THAT THE PINK TUBES ON HER CART WERE ONLY FILLING ABOUT 2MLS THEN STOPPING. SHE THEN TESTED A FEW WITH WATER AND FOUND THAT THE TWO CASES THAT WERE OPEN WERE HAVING THE ISSUE. SO WE TESTED NEW CASES RANDOMLY FROM THE SAME LOT AND THEY WORKED CORRECTLY. HOW MANY TUBES HAVE UNDERFILLED? WE TESTED ABOUT 8 TUBES AND ALL FOR THESE TWO FLATS WERE UNDERFILLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14432033 ↗
• MalfunctionNov 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) 10.8MG 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 12844854 ↗
• MalfunctionAug 18, 2021Fluid/Blood Leak; Short Fill; Volume Accuracy Problem; Fluid/Blood Leak; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED BLOOD PULLING IN THE STOPPER WELL, AND UNDERFILL OR LOW DRAW OF A TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: DESCRIBE THE EVENT OR PROBLEM: WHEN THE NURSE ATTEMPTED TO USE A BD VACUTAMER® K2 EDTA (PINK-TOP) TUBE TO DRAW BLOOD FROM THE PERIPHERAL IV START, SHE NOTICED THAT THE PXNK-TOP TUBE DIDN'T SEEM TO BE FILLING UP AT THE USUAL RATE, AND IT DIDN'T STAY CONNECTED TO THE VACUTAINER VERY WELL. THE NURSE REMOVED THE PINK-TOP LAB DRAW TUBE, AND NOTICED THAT BLOOD BEGAN SPILLING FROM THE TOP OF THE TUBE, AROUND THE AREA WHERE THE VACUTAINER INSERTS ITS NEEDLE INTO THE LAB TUBE. THE PATIENT'S BLOOD SPILLED ON THE SHEETS AND ON THE NURSE'S SCRUBS, BUT DID NOT TOUCH ANY SKIN, SO THERE WAS NOT ANY RISK OF BLOOD EXPOSURE TO NON-INTACT SKIN. THE NURSE WAS ABLE TO FIND A SECOND PINK-TOP LAB DRAW TUBE AND OBTAIN THE NECESSARY LAB DRAW. THE NURSE SAVED THE LEAKING PINK-TOP LAB DRAW TUBE SO SHE COULD PROVIDE THE LOT NUMBER, AND THEN LATER THREW THE LAB DRAW TUBE IN A BIOHAZARD CONTAINER. NO HARM OCCURRED AND NO ADDITIONAL POKES WERE OR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12339822 ↗
• MalfunctionAug 12, 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) 10.8MG BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED FOREIGN MATTER IN THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT IS REPORTED CUSTOMER WITNESSED AN NON-BIOLOGICAL FOREIGN PARTICLE. VERBIAGE RECEIVED, - 33817G VACUTAINER 6ML PINK K2EDTA 367899 0258340 X2 FOREIGN PARTICLE. 33817G VACUTAINER 6ML PINK K2EDTA 367899 0167230 X1 FOREIGN PARTICLE. NO FURTHER ATTEMPTS REQUIRED. NO SAMPLE OR FURTHER INFORMATION IS AVAILABLE PER CUSTOMER. BASED ON THE INFORMATION PROVIDED, OUR CONCLUSION IS THAT THE DEVICE CITED MEETS OUR CRITERIA OF A COMPLAINT ¿ APPENDIX A ¿ COMPLAINT DETERMINATION TREE ¿ (NASSC ¿ RCC ¿ 007).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12316013 ↗
• MalfunctionJun 28, 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) 10.8MG BLOOD COLLECTION TUBES 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 CONTAMINATION IN THE TUBES. CUSTOMER IS SEEING THE CONTAMINATION UNDER THE MICROSCOPE. PATIENTS DIDN'T HAVE TO BE REDRAWN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12079626 ↗
• MalfunctionMar 9, 2021Device Markings/Labelling Problem; Missing Information; Device Markings/Labelling Problem; Missing Information

  IT WAS REPORTED THE BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES EXPERIENCED LABEL LIFT OFF/PARTIAL PEEL OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "AS I STATED ON THE PHONE, IT MAY BE A LABEL ISSUE AND NOT A TUBE ISSUE. WE WERE TRYING TO DETERMINE THE ROOT CAUSE AND WONDERING IF THERE WAS ANY NEW TYPE OF COATING ON THE BD TUBES. SO FAR THE NEW LABEL WE USED TODAY SEEMS PROMISING, WITH ONLY ONE LABEL LIFTING OFF OF 52 TUBES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11446208 ↗
• MalfunctionJan 5, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT 2 BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES UNDERFILLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO. 367899, BATCH NO. 0184376. IT IS REPORTED CUSTOMER EXPERIENCED UNDER FILLING. VERBIAGE RECEIVED, - "PRODUCT NAME: K2 EDTA 10.8 MG PINK TOP TUBE/367899. LOT NUMBER: 0184376. ANY INJURIES AND/OR HARM: NO. WHAT IS THE ISSUE YOU EXPERIENCED: THE VACUUM DID NOT WORK AND THE TUBES WERE NOT ABLE TO BE FILLED. THIS HAPPENED WITH TWO TUBES. IS THE ACTUAL SAMPLE AVAILABLE: YES. CONTACT NAME/PHONE NUMBER: (B)(6)."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11121341 ↗
• MalfunctionAug 19, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE PRODUCT WAS DIRTY/STAINED. DIRTY/STAINED".

  Patient problems: No Patient Involvement

  MAUDE report 10429246 ↗
• MalfunctionAug 19, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE PRODUCT WAS DIRTY/STAINED. DIRTY/STAINED".

  Patient problems: No Patient Involvement

  MAUDE report 10429226 ↗