BD Vacutainer® K2 EDTA (K2E) 3.6mg Blood Collection Tubes 367842Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 30382903678427), received between May 2, 2018 and Apr 29, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Short Fill” (8 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2025Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES THERE WAS INSUFFICIENT BLOOD DRAW VOLUME IN AN UNSPECIFIED NUMBER OF DEVICES. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21927109 ↗
• MalfunctionAug 11, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES THAT THERE WAS DISCOLORED / ABNORMAL ADDITIVE FORM IN THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES - "WE HAVE ANOTHER QA ISSUE AND ARE WORKING TO DETERMINE HOW MANY WE HAVE OF THE AFFECTED LOTS." THEY APPEAR AS THOSE MOISTURE IS INSIDE THE VACUTAINER AND THE ORDER JUST ARRIVED TODAY (B)(6) 2023."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17508848 ↗
• MalfunctionAug 9, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES HAD CONDENSATION IN THE TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY ARE HAVING A CONDENSATION ISSUE WITH ITEM 367842.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17492765 ↗
• MalfunctionMar 17, 2023Separation Problem; Separation Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBE THE STOPPER POPS OUT OF THE TUBE. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TUBE CAP CAME OFF ON TWO OCCASIONS THUS RESULTING IN DECAPPING ISSUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16562777 ↗
• MalfunctionAug 10, 2022Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 3.6MG 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: "MULTIPLE PINK TOP TUBES ARE UNDERFILLING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15203884 ↗
• MalfunctionMay 31, 2022Product Quality Problem; Product Quality Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBE THERE WAS A STERILITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "ONE PC TUBE WITHOUT THE HEMOGARD CLOSURE WAS RECEIVED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14552660 ↗
• MalfunctionOct 12, 2020Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED DURING USE THE BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED "THE TUBE THAT WE RECENTLY STARTED USING DOES NOT ¿FILL UP¿ THE WAY THAT OTHER BD VACUTAINER TUBES DO. WE EVEN HAD TWO REPORTS THIS PAST WEEK THAT THE TUBE, WHEN USED PERIPHERALLY, STOPPED FILLING BELOW THE FILL LINE AND THE BLOOD IN THE BUTTERFLY NEEDLE STARTED TO ¿BACK UP¿ INTO THE PATIENT."

  Patient problems: No Patient Involvement

  MAUDE report 10667464 ↗
• MalfunctionApr 27, 2020Overfill; Overfill

  IT WAS REPORTED THAT OVERFILL OCCURRED DURING USE WITH A BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. "IT WAS REPORTED THAT THE PRODUCT WAS FOUND TO HAVE DRAW VOLUME GREATER THAN THE UPPER SPEC LIMIT OF 5.5ML. UPON DATA ANALYSIS AND REVIEW, PRODUCT FOR ONE LOT OF 367842 WAS FOUND TO HAVE DRAW VOLUME GREATER THAN THE UPPER SPEC LIMIT OF 5.5ML. 2 FAILURE OF 30 TESTED. PRODUCT IS REQUIRED TO MEET 99% RELIABILITY WITH 95% CONFIDENCE AGAINST THE USL, BUT A STATISTICAL ANALYSIS SHOWS THAT THIS LOT IS UNLIKELY TO BE MEETING THAT REQUIREMENT. PPK REQUIREMENT IS = 1.02 FOR A SAMPLE SIZE OF 30. THIS LOT HAS A PPK OF 0.50. PRODUCT WAS EXPOSED TO A DOUBLE DOSE OF STERILIZATION MIN DOSE: 15.6KGY, MAX DOSE: 21.8KGY. R&D SENIOR MANAGER PERFORMING DATA ANALYSIS AND REVIEW OF TUBE 367842, AND THE DRAW VOLUME WAS GREATER THAN THE UPPER SPEC LIMIT OF 5.5ML, SO IT WAS OVERFILLING."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10002100 ↗
• MalfunctionDec 5, 2019Short Fill; Short Fill

  IT WAS REPORTED THAT TUBES ARE UNDER FILLING WITH A BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT TUBES NOT FILLING COMPLETELY. ADDITIONAL INFORMATION RECEIVED: THE PINK TOP TUBE DID NOT FILL UP TO THE 2 ML MARK (SHOULD BE THE SAME AS THE LAVENDER). I DID THE SAME AT WP BUT THIS TIME I USED A CALIBRATED PIPETTE TO GET EXACTLY 2 ML INTO THE PINK AND THE LAVENDER WAS THE SHORTER ONE. FUNNY THING IS THAT I HAVE SOME IN THE CAR WHICH I FILLED UP EARLIER IN THE WEEK WITH GLUCOLA AND THOSE (PINK AND LAV.) ARE AT EXACTLY THE SAME LEVEL BUT SLIGHTLY BELOW THE MARK ON THE MANUFACTURER LABEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9415525 ↗
• MalfunctionNov 21, 2019Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT 3 BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES EXPERIENCED UNDER FILL OR LOW DRAW OF A TUBE WITH BLOOD DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367842, BATCH NO. UNKNOWN. CUSTOMER COMPLAINED ABOUT TUBES NOT FILLING COMPLETELY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9355982 ↗
• MalfunctionOct 7, 2019Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT THERE WAS LOW BLOOD DRAW WITH A BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES. THIS OCCURRED ON 20 SEPARATE OCCASIONS, HOWEVER, THE PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED 20 VACUTAINERS DISPLAYED NO VACUUM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9161921 ↗
• MalfunctionJun 27, 2019Overfill; Overfill

  IT WAS REPORTED THAT TWO BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES EXPERIENCED OVERFILL DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT DURING R&D TESTING IN BD FRANKLIN LAKES, INSTANCES WERE IDENTIFIED WHERE THE TUBE DRAW VOLUME WAS OUTSIDE OF THE SPECIFICATIONS. DRAW VOLUMES WERE ABOVE 2.2ML (2.21 & 2.23ML) EVENT DESCRIPTION PER INITIAL REPORTER EMAIL STATES, DURING R&D TESTING, WE HAVE IDENTIFIED INSTANCES WHERE THE TUBE DRAW VOLUME WAS OUTSIDE OF OUR SPECIFICATIONS. THE SPECIFIC PRODUCT SKU AND BATCH NUMBERS WHERE THIS OCCURRED ARE LISTED BELOW. EVENT DATE: (B)(6) 2019, AWARENESS DATE: 12 JUN 2019, CATALOG #: 367841, BATCH #: 9065784, OBSERVATION: DRAW VOLUMES ABOVE 2.2ML (2.21 & 2.23ML).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8742146 ↗
• MalfunctionFeb 14, 2019Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT A BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES WERE UNDERFILLING. THIS OCCURRED ON 50 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8340659 ↗
• MalfunctionFeb 9, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A BASED ON A STUDY FOR HEMOLYSIS THERE WAS A NEED FOR RECOMMENDED SPEED FOR CENTRIFUGATION FOR BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8324505 ↗
• MalfunctionJun 14, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES HAD DEFECTIVE STOPPERS. 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 7601278 ↗
• MalfunctionJun 13, 2018Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES HAD LOW DRAW. NO REPORT OF MEDICAL INTERVENTION OR SERIOUS INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7598355 ↗
• 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) 3.6MG BLOOD COLLECTION TUBES WERE DIRTY. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7597927 ↗
• MalfunctionMay 8, 2018Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES WERE UNDERFILLED.

  Patient problems: No Information

  MAUDE report 7495995 ↗
• MalfunctionMay 2, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT BD VACUTAINER® K2 EDTA (K2E) 3.6 MG BLOOD COLLECTION TUBES WAS UNDER FILLING WHICH COULD LEAD TO ERRONEOUS RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7481947 ↗