BD Vacutainer® Serum 367812Recalls & reported problems

Summary

The FDA's MAUDE database contains 244 adverse event reports that list this exact device (DI 30382903678120), received between Nov 27, 2017 and Sep 22, 2026 — classified as 244 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (61 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 244 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862901 ↗
• MalfunctionSep 10, 2026Short Fill

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716226 ↗
• MalfunctionSep 9, 2026Fluid/Blood Leak; Unsealed Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50700880 ↗
• MalfunctionSep 9, 2026Microbial Contamination of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695171 ↗
• MalfunctionMay 28, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, A FOREIGN OBJECT WAS FOUND INSIDE OF ONE TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25319050 ↗
• MalfunctionMay 7, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, WHITE FLOCCULENT FOREIGN MATTER WAS FOUND IN ONE (1) TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25118878 ↗
• MalfunctionMay 5, 2026Separation Problem

  IT WAS REPORTED AFTER USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, THE STOPPER POPPED OFF OF ONE (1) TUBE CAUSING THE SAMPLE TO SPILL. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25088904 ↗
• MalfunctionApr 21, 2026Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, 40 TUBES UNDERFILLED AND WHEN INSPECTED HAD CRACKS IN THE STOPPERS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24947621 ↗
• MalfunctionApr 6, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, WHITE FOREIGN MATTER WAS SEEN INSIDE OF ONE TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793620 ↗
• MalfunctionApr 1, 2026Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, 200 TUBES PUSHED OFF THE NON PATIENT NEEDLE AND UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757600 ↗
• MalfunctionMar 24, 2026Fluid/Blood Leak; Separation Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, THE CAP OF ONE TUBE CREPT OPEN DURING PNEUMATIC TRANSPORT RESULTING IN SAMPLE LEAKAGE IN THE TRANSPORT CONTAINER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681979 ↗
• MalfunctionMar 9, 2026Backflow

  IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, WHEN THE TUBE IS INSERTED INTO THE BUTTERFLY NEEDLE, THE BLOOD BEGINS TO BACKFLOW UP THE TUBE AND INTO THE PATIENTS ARM. THIS OCCURRED AN UNSPECIFIED NUMBER OF TIMES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24553025 ↗
• MalfunctionMar 6, 2026Backflow

  IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, WHEN THE TUBE IS INSERTED INTO THE HUB OF THE BUTTERFLY, BLOOD STARTS MOVING THROUGH THE TUBING THEN IT'S PUSHED BACK INTO THE VEIN OF THE PATIENT. THIS OCCURRED AN UNSPECIFIED NUMBER OF TIMES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24537403 ↗
• MalfunctionMar 2, 2026Separation Problem

  IT WAS REPORTED AFTER USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, THERE WERE STOPPER POPS OFF SEEN IN 21TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24490019 ↗
• MalfunctionFeb 18, 2026Separation Failure

  IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, CLOSURE SEPARATION BETWEEN THE CAP AND THE RUBBER STOPPER OCCURRED WITH TWO TUBES WHILE ON THE ANALYZER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378305 ↗
• MalfunctionFeb 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED AFTER USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, THE AUTOMATED DECAPPER FAILED TO REMOVE THE CAP OF ONE (1) TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24335116 ↗
• MalfunctionFeb 11, 2026Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, ONE (1) TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24315486 ↗
• MalfunctionFeb 6, 2026Separation Problem

  IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® SERUM, THE RUBBER STOPPER REMAINED IN TWO (2) TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283085 ↗
• MalfunctionFeb 6, 2026Separation Problem

  IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, BLOOD SPILLS OUT OF THE TUBE AFTER THE CAP IS PUT BACK ONTO THE TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283082 ↗
• MalfunctionFeb 5, 2026Separation Failure

  IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, 1 TUBE EXHIBITED CLOSURE SEPARATION WHERE THE SHIELD WAS SEPARATED FROM THE STOPPER DURING PROCESSING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268278 ↗
• MalfunctionJan 29, 2026Separation Failure

  IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® SERUM TUBES, TWO (2) TUBES EXHIBITED THE STOPPER SEPARATING FROM THE CAP AND REMAINING IN THE TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24214580 ↗
• MalfunctionJan 29, 2026Separation Problem

  IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® SERUM TUBES, TWO (2) TUBES EXHIBITED THE STOPPER SEPARATED FROM THE CAP AND STUCK IN THE TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24214570 ↗
• MalfunctionJan 29, 2026Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® SERUM TUBES, THE CAP OF EIGHT (8) TUBES DID NOT FIT TIGHTLY AFTER BEING FILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24211275 ↗
• MalfunctionJan 27, 2026Separation Failure

  REPORT 2 OF 2: IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® SERUM TUBE, THE CAP COULD NOT BE REMOVED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192744 ↗
• MalfunctionJan 27, 2026Separation Failure

  REPORT 1 OF 2: IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® SERUM TUBES, THE CAP COULD NOT BE REMOVED FROM FOUR (4) TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192742 ↗

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.