BD Vacutainer® K3 EDTA (K3E) 12 mg Blood Collection Tubes 366450Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 30382903664505), received between May 1, 2018 and Oct 29, 2019 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD VACUTAINER® K3 EDTA (K3E) BLOOD COLLECTION TUBE DID NOT MEET THE MEAN FORCE SPECIFICATION FOR STOPPER REMOVAL/LOOSE CLOSURE BEFORE USE DURING R&D TESTING. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING R&D TESTING, WE OBSERVED SOME TUBES WITH 2ND TIME STOPPER REMOVAL FORCES THAT DID NOT MEET THE MINIMUM FORCE SPECIFICATION. WE ALSO OBSERVED 1 BATCH OF TUBES THAT DID NOT MEET THE MEAN FORCE SPECIFICATION. THE PRODUCT INFORMATION IS LISTED BELOW. CATALOG #366430, BATCH #9095718, TEST DATE: (B)(6) 2019, DATA REVIEW DATE: 14 OCT 2019. OBSERVATION DID NOT MEET MINIMUM FORCE SPECIFICATION. 366668, 9122779, (B)(6) 2019, 14 OCT 2019. DID NOT MEET MINIMUM FORCE SPECIFICATION. 367729, 9184898, (B)(6) 2019, 14 OCT 2019. DID NOT MEET MINIMUM FORCE SPECIFICATION. 366450, 9095722, (B)(6) 2019, 14 OCT 2019. DID NOT MEET MEAN FORCE SPECIFICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9250805 ↗
• MalfunctionFeb 13, 2019Break; Break

  IT WAS REPORTED THAT THE BD VACUTAINER® K3 EDTA (K3E) BLOOD COLLECTION TUBE BROKE "IN STORAGE AFTER FREEZING".

  Patient problems: No Information

  MAUDE report 8335920 ↗
• MalfunctionJul 18, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD VACUTAINER® K3 EDTA (K3E) 12MG BLOOD COLLECTION TUBES HAD DARK CLUMPS IN THE TUBE WHICH ARE POSSIBLY FOREIGN MATERIAL. 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 7698915 ↗
• MalfunctionMay 9, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD VACUTAINER® VENOUS BLOOD COLLECTION TUBES ARE BREAKING DURING THE CENTRIFUGE PROCESS. NO EXPOSURE TO BODILY FLUID. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7500922 ↗
• MalfunctionMay 9, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT BD VACUTAINER® K3 EDTA (K3E) 12MG BLOOD COLLECTION TUBES WERE UNDERFILLED.

  Patient problems: No Information

  MAUDE report 7500568 ↗
• MalfunctionMay 1, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT THE BD VACUTAINER® K3 EDTA (K3E) 12MG BLOOD COLLECTION TUBES HAD CLOTTING ISSUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7477716 ↗