BD Vacutainer® K2 EDTA (K2E) 10.8 mg Blood Collection Tubes 368661Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 30382903686613), received between Nov 27, 2017 and Aug 20, 2020 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (8 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO USE FOREIGN MATTER WAS DISCOVERED WITH 3 BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE PRODUCT WAS DIRTY/STAINED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10431939 ↗
• MalfunctionAug 19, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS DISCOVERED PRIOR TO USE WITH 7 BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE WAS PARTICULATE IN THE PRODUCT.

  Patient problems: No Patient Involvement

  MAUDE report 10426302 ↗
• MalfunctionAug 12, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BEFORE USE THE BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES HAD FOREIGN MATTER IN TUBE; BIOLOGICAL AND NONBIOLOGICAL. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER FOUND THERE WAS PARTICULATE IN THE PRODUCT."

  Patient problems: No Patient Involvement

  MAUDE report 10399464 ↗
• MalfunctionAug 12, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BEFORE USE THE BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES HAD FOREIGN MATTER IN TUBE; BIOLOGICAL AND NONBIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER FOUND THERE WAS PARTICULATE IN THE PRODUCT.".

  Patient problems: No Patient Involvement

  MAUDE report 10399462 ↗
• MalfunctionApr 2, 2020Overfill; Overfill

  IT WAS REPORTED THAT THE BD VACUTAINER® K2 EDTA (K2E) BLOOD COLLECTION TUBE OVERFILLED DURING USE AND WOULD NOT PIPETTE AS A RESULT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD SEVERAL REPORTS FROM THE LAB THAT PERFORMS OUR TESTING THAT THE GREINER TUBES ARE ¿OVERFILLING¿ - BABESIA TUBES HAVE TOO MUCH VOLUME IN THEM. IT AFFECTS THE EQUIPMENT WHEN PIPETTING. THE EQUIPMENT HAS A SENSOR AND WHEN THE LEVELS ARE HIGHER THAN THEY SHOULD BE, IT WILL NOT PIPETTE. SOME BLOOD MUST BE REMOVED TO ALLOW PIPETTING TO OCCUR." "THE LAB STATED THEY BEGAN TO SEE THESE HIGH VOLUME TUBES IN JANUARY AND FEBRUARY. IT APPEARS TO BE OCCURRING SPORADICALLY WITHIN THE LOT. SOMEDAY THE LAB RECEIVED ONLY A HANDFUL OF HIGH VOLUME TUBES, AND OTHER DAYS THEY STATE THEY ARE GETTING HIGH NUMBERS OF THEM."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9916076 ↗
• MalfunctionMar 30, 2020Overfill; Overfill

  IT WAS REPORTED THAT THE TUBES ARE OVER FILLING WITH A BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE HAD SEVERAL REPORTS FROM THE LAB THAT PERFORMS OUR TESTING THAT THE GREINER TUBES ARE ¿OVERFILLING¿ - BABESIA TUBES HAVE TOO MUCH VOLUME IN THEM. IT AFFECTS THE EQUIPMENT WHEN PIPETTING. THE EQUIPMENT HAS A SENSOR AND WHEN THE LEVELS ARE HIGHER THAN THEY SHOULD BE, IT WILL NOT PIPETTE. SOME BLOOD MUST BE REMOVED TO ALLOW PIPETTING TO OCCUR. ADDITIONALLY, ON 2020-03-13 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: SPOKE WITH THE CUSTOMER, SHE ASSURED ME THAT THE COMPLAINT IS REGARDING BD TUBES, EVEN THOUGH GREINER TUBES ARE MENTIONED IN THE EMAIL. SHE STATED THAT THEY USE BOTH BD AND GREINER TUBES. THE ANALYZER IS REJECTING THE TUBES, WITH FLAGS THAT THE TUBES ARE OVERFILLLED. I SUGGESTED THAT THE ANALYZER BE CALIBRATED. I ASKED IF THE TUBES ARE CLOTTING, AS THERE WOULD NOT BE ENOUGH ANTICOAGULANT IN THE TUBES TO PREVENT CLOTTING. SHE WILL CHECK INTO THAT. THE TUBES ARE DRAWN USING A WHOLE BLOOD COLLECTION SET (AMICUS KIT). SHE WILL SEND PICTURES OF HOW THE BLOOD IS DRAWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9899290 ↗
• MalfunctionMar 24, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS DISCOVERED IN THE TUBES PRIOR TO USE WITH A BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SITE FOUND BLACK SPOTS IN THE TUBES. HOW MANY TUBES FROM EACH LOT CONTAINED THE BLACK SPOTS? ONLY ONE TUBE FROM LOT# 9280963 AND OVER 50 FROM LOT# 9095813, DIDN¿T OPEN ALL OF THE PACKS ALTHOUGH THE SPOTS ON A FEW TUBES FROM EACH PACK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9871756 ↗
• MalfunctionFeb 19, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS STOPPER CREEP AS WELL AS STOPPER COMES OFF AFTER USE WITH A BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THAT AFTER SAMPLE WAS COLLECTED AND AT THE PROCESSING STATION, THE STOPPER CAME OFF. CUSTOMER LOOKED AT OTHER TUBES IN THIS SAME LOT# IT APPEARED THESE STOPPER WERE ALSO LOOSE AND NOT FIRMLY SEATED IN THE TUBE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9727211 ↗
• MalfunctionAug 8, 2019Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT HAS BEEN REPORTED THAT THE BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES HAS BEEN FOUND EXPERIENCING MOLDING DEFECTS. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED PURPLE TOP TUBES WERE DEFORMED. THIS IS TO INFORM YOU ON (B)(6) 2019 STAFF DISCOVERED THAT ABOUT 15-20 EDTA 6ML PURPLE TOP TUBES WERE DEFORMED, FROM LOT NUMBER 8156830. VERBATIM IN ATTACHMENT: DURING QC FUNCTION CHECKS, IT WAS DISCOVERED THAT ABOUT 15-20 EDTA 6ML PURPLE TOP TUBES WERE DEFORMED, FROM LOT NUMBER 8156830.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8874974 ↗
• MalfunctionMay 30, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT LABEL ERROR OCCURRED WITH A BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE EXPIRATION AND THE BATCH NUMBERS ON THE BOXES ARE BLURRY. 2 SHELF PACKS WERE AFFECTED.''

  Patient problems: No Information

  MAUDE report 8654895 ↗
• MalfunctionMay 22, 2019Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT TUBE PUSH OFF OCCURRED WITH A BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT THE TUBES ARE SPONTANEOUSLY DISENGAGING FROM MULTI-SAMPLE NEEDLES. TUBES SPONTANEOUSLY DISENGAGE FROM MULTI-SAMPLE NEEDLES, EXPIRATION DATES ARE 8/2019. THESE ITEMS ARE USED BY 2 DIFFERENT PROGRAMS SO WE HADN'T REALIZED THEY WERE A MANUFACTURING PROBLEM UNTIL NOW. WOULD LIKE TO EXCHANGE FOR TUBES WITH 2021 OR LATER, EXPIRATION DATE, PLEASE. 6.0ML LAVENDERS: LOT: 8156830 EXP: 11/30/2019 ¿ 9 BOXES. COMPLAINT 1 OF 5.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8632732 ↗
• MalfunctionApr 22, 2019Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT THERE WERE 4 OCCURRENCES WHERE TUBES HAD DEFECTS WITH A BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE TUBE APPEARED TO BE MELTED. THEY FOUND A TOTAL OF 4 TUBES THAT APPEARED MELTED NEAR THE STOPPER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8537351 ↗
• MalfunctionFeb 4, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A SINGLE BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES CRACKED WITH BLOOD IN IT WHILE FREEZING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8302658 ↗
• MalfunctionFeb 4, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBE EXPERIENCED TUBE CRACKING WHEN FROZEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8302500 ↗
• MalfunctionDec 17, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES WERE UNDERFILLING.

  Patient problems: No Information

  MAUDE report 8169370 ↗
• MalfunctionJun 13, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES WERE WARPED AT THE TOP. NO SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7599226 ↗
• MalfunctionJun 13, 2018Device 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 HAD FM IN THE TUBES. NO REPORT OF MEDICAL INTERVENTION OR SERIOUS INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7596342 ↗
• MalfunctionJun 12, 2018Device 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. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7594411 ↗
• MalfunctionJun 7, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES WERE UNDERFILLING. NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO REPORT OF BLOOD EXPOSURE TO MUCOUS MEMBRANE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7579815 ↗
• MalfunctionMay 29, 2018Device 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 HAD FOREIGN MATTER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7551385 ↗
• MalfunctionMay 9, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES HAD PART OF THE STOPPER MISSING FROM THE TUBE.

  Patient problems: No Information

  MAUDE report 7500875 ↗
• MalfunctionMay 7, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES HAD "ADDITIVE ABNORMALITY."

  Patient problems: No Information

  MAUDE report 7491260 ↗
• MalfunctionApr 26, 2018Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES HAD CLOTTING IN TUBES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7466312 ↗
• MalfunctionApr 26, 2018Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG HAD CLOTTING ISSUES. NO SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7466307 ↗
• MalfunctionDec 6, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE BD VACUTAINER¿ PLASTIC BLOOD COLLECTION TUBES WITH K2EDTA, LAVENDER CONVENTIONAL STOPPER, 6.0 ML DRAW, 13X100 MM WAS CLOTTING. NO INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7087273 ↗

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.