BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes 367855Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 30382903678557), received between Dec 8, 2017 and Apr 19, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Short Fill” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2023Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES THAT THERE WAS CLOTTING/MICROCLOTS/FIBRIN CLOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: CUSTOMER STATES - ONGOING ISSUES WITH MICRO-CLOTTING WITH 367855 DURING ASPIRATION. SM 367855 MICRO- CLOTTING DURING ASPIRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16770819 ↗
• MalfunctionDec 12, 2022Short Fill; Short Fill

  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: "THE TUBES HAVE LOW DRAW VOLUME."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15958771 ↗
• MalfunctionApr 27, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 3 BD VACUTAINER® LH 102 I.U. PLUS BLOOD COLLECTION TUBES CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CURLS OF PLASTIC INSIDE LIHEP TUBES "A STAFF MEMBER RAISED THAT SHE WAS NOTICING LUMPS OF PLASTIC ON THE SIDE OF BD VACUTAINER TUBES. I ASKED THAT SHE LOOKOUT FOR AN EXAMPLE WHICH SHE HAS DONE AND PICTURES ARE ATTACHED, THE PARTICULAR TUBE USED AN EXAMPLE IS A LIHEP 6.0 ML PST BD VACUTAINER TUBE. ACCORDING TO STAFF SOME TUBES HAVE A LUMP OF PLASTIC ON THE SIDE, THE PARTICULAR ONE IN THE EXAMPLE HAS A FLAP OF PLASTIC AND ALMOST APPEAR TO HAVE A DELAMINATED AREA IN THE MOULDING. I AM WORRIED THAT THIS COULD POTENTIALLY RESULT IN SAMPLING ISSUES AS WE SAMPLE DIRECTLY FROM PRIMARY TUBES AND PROBES COULD BE TOUCHING THE PLASTIC OR HAVING IT BLOCK SAMPLE ASPIRATION. OTHER ISSUES MAY INCLUDE PREMATURE TRIGGERING OF CLOTTING PRIOR TO ACTIVATION OF LIHEP.""

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11732800 ↗
• MalfunctionSep 16, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AFTER USE WITH 3 BD VACUTAINER® EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES IT WAS DISCOVERED THAT THE TUBES WERE EXPIRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LAB MANAGER CALLED IN REQUESTING INFORMATION IN REGARDS TO USING EXPIRED VACUTAINERS AND THE POSSIBLE OUTCOMES. NO DATE OF EVENT, 3 OCCURRENCES AT THIS TIME. THERE IS NO ERRONEOUS RESULTS TO REPORT AT THIS TIME BUT PATIENTS WILL BE CALLED IN TO BE REDRAWN. NO LOT INFORMATION AT THIS TIME BUT EXPIRATION DATE WAS 07/31/2020.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10544042 ↗
• MalfunctionJan 8, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF A BD VACUTAINER® K2 EDTA (K2E) BLOOD COLLECTION TUBE WERE GIVING ERRONEOUS RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8227895 ↗
• MalfunctionDec 3, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD VACUTAINER® K2 EDTA (K2E) BLOOD COLLECTION TUBES WERE GIVING ERRONEOUS RESULTS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8125317 ↗
• MalfunctionMay 10, 2018Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES THERE WAS AN INCREASE IN CLOTTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7504825 ↗
• MalfunctionApr 25, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES HAD LOW DRAW.

  Patient problems: No Information

  MAUDE report 7462543 ↗
• MalfunctionApr 18, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES UNDER FILLED.

  Patient problems: No Information

  MAUDE report 7440802 ↗
• MalfunctionDec 8, 2017Suction Problem

  IT WAS REPORTED THAT THE 3.0ML BD VACUTAINER® PLUS VENOUS BLOOD COLLECTION TUBE WAS ONLY DRAWING 2.6ML OF BLOOD. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7101040 ↗

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.