BD Vacutainer® K2 EDTA (K2E) 18 mg Blood Collection Tubes 368589Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 30382903685890), received between May 10, 2018 and May 13, 2022 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Coagulation in Device or Device Ingredient” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2022Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 18 MG BLOOD COLLECTION TUBE THERE WAS UNDER-FILL 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: "THE CUSTOMER IS EXPERIENCING A LOW DRAW VOLUME."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14388227 ↗
• MalfunctionApr 8, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE BD VACUTAINER® K2 EDTA (K2E) 18 MG BLOOD COLLECTION TUBES EXPERIENCED DISCOLORED / ABNORMAL ADDITIVE FORM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "I AM REACHING OUT AS RELATED TO THE 10 ML K2EDTA TUBE, LOT #0167257, EXP 06-30-22. WE ARE SEEING ISSUES NOW WITH APPROXIMATELY 6-7 SPECIMENS IN WHICH THE PLASMA IS DESCRIBED AS BEING LIKE JELLY. ".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11636080 ↗
• MalfunctionApr 8, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE BD VACUTAINER® K2 EDTA (K2E) 18 MG BLOOD COLLECTION TUBES EXPERIENCED DISCOLORED / ABNORMAL ADDITIVE FORM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "I AM REACHING OUT AS RELATED TO THE 10 ML K2EDTA TUBE, LOT #0167257, EXP 06-30-22. WE ARE SEEING ISSUES NOW WITH APPROXIMATELY 6-7 SPECIMENS IN WHICH THE PLASMA IS DESCRIBED AS BEING LIKE JELLY. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11636053 ↗
• MalfunctionApr 8, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE BD VACUTAINER® K2 EDTA (K2E) 18 MG BLOOD COLLECTION TUBES EXPERIENCED DISCOLORED / ABNORMAL ADDITIVE FORM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "I AM REACHING OUT AS RELATED TO THE 10 ML K2EDTA TUBE, LOT #0167257, EXP 06-30-22. WE ARE SEEING ISSUES NOW WITH APPROXIMATELY 6-7 SPECIMENS IN WHICH THE PLASMA IS DESCRIBED AS BEING LIKE JELLY. ".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11636001 ↗
• MalfunctionApr 7, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE BD VACUTAINER® K2 EDTA (K2E) 18 MG BLOOD COLLECTION TUBES EXPERIENCED DISCOLORED / ABNORMAL ADDITIVE FORM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT THE PLASMA LOOKS LIKE JELLY. "I AM REACHING OUT AS RELATED TO THE 10 ML K2EDTA TUBE, LOT #0167257, EXP 06-30-22. WE ARE SEEING ISSUES NOW WITH APPROXIMATELY 6-7 SPECIMENS IN WHICH THE PLASMA IS DESCRIBED AS BEING LIKE JELLY. HAVE YOU HEARD OF ANY ISSUES OF THIS NATURE FROM ANYWHERE ELSE. WE ARE WONDERING IF IT IS THIS SPECIFIC LOT NUMBER ALONE, AS THIS IS THE ONLY LOT NUMBER WE CURRENTLY HAVE ON HAND FOR BOTH OF OUR HOSPITAL CAMPUSES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11628541 ↗
• MalfunctionNov 10, 2020Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® K2 EDTA (K2E) 18 MG BLOOD COLLECTION TUBES THERE WAS CLOTTING/MICRO CLOTS/FIBRIN CLOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED "THE TUBES ARE ALSO CLOTTING AT THE (B)(6) HOSPITAL AT (B)(6) . THEY HAVE 2 LOTS OF THE PINK-TOP TUBES, ONE HAD NO PROBLEMS BUT THE OTHER CLOTS."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10819918 ↗
• MalfunctionNov 4, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT PRIOR TO USE WITH A BD VACUTAINER® K2 EDTA (K2E) 18 MG BLOOD COLLECTION TUBES THE TUBES WERE DISCOVERED TO BE MISSING ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE TUBES ARE MISSING GEL OR POWDER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10786995 ↗
• MalfunctionNov 3, 2020Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® K2 EDTA (K2E) 18 MG BLOOD COLLECTION TUBES EXPERIENCED CLOTTING/MICRO CLOTS/FIBRIN CLOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED "TUBES ARE USED FOR AUTOMATED BLOOD BANK, BUT WE HAVE BEEN HAVING PROBLEMS WITH THIS LOT NUMBER CLOTTING. THE TUBES ARE LABELED CORRECTLY AS K2 EDTA BUT THE LIQUID IN THE TUBE IS INCORRECT. I BELIEVE IT IS CLOT ACTIVATOR INSTEAD OF ANTICOAGULANT."

  Patient problems: No Patient Involvement

  MAUDE report 10782258 ↗
• MalfunctionOct 22, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS DISCOVERED WITH A BD VACUTAINER® K2 EDTA (K2E) 18 MG BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE TUBE WAS DIRTY/STAINED.

  Patient problems: No Patient Involvement

  MAUDE report 10718616 ↗
• MalfunctionOct 16, 2020Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED AFTER USE THE BD VACUTAINER® K2 EDTA (K2E) 18 MG BLOOD COLLECTION TUBES HAD CLOTTING/MICRO/CLOTS/FIBRIN CLOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED "THE TUBES ARE CLOTTING CAUSING THE PATIENTS TO BE REDRAWN. WE ARE HAVING AN ISSUE WITH OUR BLOOD BANK TUBES, SOME IN THE LOT # 0167257 ARE CLOTTING AND PATIENTS ARE HAVING TO BE REDRAWN.¿

  Patient problems: No Patient Involvement

  MAUDE report 10691958 ↗
• MalfunctionSep 30, 2020Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT AFTER USE WITH A BD VACUTAINER® EDTA (K2E) 18 MG BLOOD COLLECTION TUBES THE SAMPLES WERE CLOTTED. THIS OCCURRED WITH SEVERAL PATIENT SAMPLES, HOWEVER, PATIENT INFORMATION IS UNKNOWN. SOME PATIENTS HAD A DELAY IN RESULTS OTHERS REQUIRED ADDITIONAL NEEDLE STICKS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SAMPLES WERE CLOTTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10608248 ↗
• MalfunctionSep 28, 2020Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED AFTER USE THE BD VACUTAINER® EDTA (K2E) 18 MG BLOOD COLLECTION TUBES EXPERIENCED CLOTTING/MICRO CLOTS/FIBRIN CLOTS. THIS EVENT OCCURRED 6 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED "THE PINK TOP TUBES THAT HAVE BEEN USED TO COLLECT BLOOD BANK SAMPLES. FOR SOME REASON, THESE TUBES ARE CAUSING THE BLOOD TO CLOT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10597394 ↗
• 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) 18 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 10429248 ↗
• MalfunctionOct 24, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT TUBES ARE HAVING ISSUES WITH HEMOLYSIS WITH A BD VACUTAINER® K2 EDTA (K2E) 18 MG BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT TUBES ARE HAVING ISSUES WITH HEMOLYSIS. ADDITIONAL INFORMATION PROVIDED BY CUSTOMER: IT WAS DRAWN WITH NO PROBLEMS WITH A REGULAR NEEDLE AND SENT THROUGH THE TUBE SYSTEM. WE DON¿T HAVE ANY FOAM IN THE TRANSPORT TUBES BUT ARE GOING TO TRY AND GET SOME TO TRY OUT. WAS IT A DIFFICULT VENIPUNCTURE? WAS THERE ANY ¿PROBING"" AT THE VENIPUNCTURE SITE? DON¿T KNOW. HOW LONG DID IT TAKE TO FILL THE TUBES? DON¿T KNOW. WAS THE BLOOD, IF TRANSFERRED FROM A SYRINGE, FORCED INTO THE TUBE? WAS NOT TRANSFERRED. HOW LONG WAS THE TOURNIQUET LEFT ON THE ARM DURING VENIPUNCTURE? SHE USUALLY POPS THE TOURNIQUET WHEN BLOOD STARTS COMING, BUT NOT ALWAYS. HOW ARE THE TUBES BEING MIXED (GENTLY OR VIGOROUSLY)? GENTLE INVERSION. WAS THE ANTISEPTIC USED TO CLEANSE THE SITE ALLOWED TO DRY BEFORE THE VENIPUNCTURE? YES. WAS THERE ANY MOISTURE PRESENT IN THE TUBE? DID WATER, OR OTHER SOLUTIONS, ENTER THE TUBE? NOT THAT WE NOTICED. WERE ALL THE TUBES FROM THIS PATIENT HEMOLYZED? WAS THERE A COMPARISON OF VAR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9234420 ↗
• MalfunctionAug 3, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD VACUTAINER® K2 EDTA (K2E) 18 MG BLOOD COLLECTION TUBES CONTAINED FOREIGN MATTER THAT APPEARS TO BE A HAIR. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7748156 ↗
• MalfunctionMay 10, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® K2 EDTA (K2E) 18 MG BLOOD COLLECTION TUBES, THERE WAS ONE TUBE THAT WAS DIFFICULT TO PUNCTURE RESULTING IN BLOOD SPATTER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7503533 ↗

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.