BD Vacutainer® K2 EDTA 5.4 mg Blood Collection Tubes 368054Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30382903680543), received between Jul 14, 2020 and Jul 15, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Short Fill” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2020Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THE TUBE EDTA PLH 13X75 3.0 PLBL LAV BC EXPERIENCED UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE MED TECH WAS WANTING INFORMATION IN REGARDS TO MINIMUM AND MAXIMUM DRAW FOR THIS PRODUCT. THEY ARE EXPERIENCING LOW DRAW VOLUME. NO SPECIFIC LOT INVOLVED, THEY HAVE NOTICED THIS IS AN ON-GOING ISSUE. EVENT HAPPENS OVER MULTIPLE LOTS, DRAWN BY 22 GAUGE NEEDLES, BUTTERFLIES ARE RARELY USED, UPON RECEIPT OF TUBES ARE AIR CONDITIONED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10276799 ↗
• MalfunctionJul 14, 2020Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THE UNSPECIFIED VACUTAINER BLOOD COLLECTION TUBE HAD UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER IS EXPERIENCING SLOW FILLING VACUTAINERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10269526 ↗

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.