BD Vacutainer® Serum Plus Blood Collection Tubes 367819Recalls & reported problems

Summary

The FDA's MAUDE database contains 124 adverse event reports that list this exact device (DI 30382903678199), received between Apr 10, 2018 and Apr 3, 2026 — classified as 124 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (42 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 25 most recent of 124 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Separation Problem

  IT WAS REPORTED DURING RECAPPING OF BD VACUTAINER® SERUM PLUS BLOOD COLLECTION TUBES, THE CAP OF ONE TUBE DID NOT FIT PROPERLY, FAILED TO SEAL, AND DETACHED ON ITS OWN. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781639 ↗
• MalfunctionFeb 26, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM PLUS BLOOD COLLECTION TUBES, 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 24462002 ↗
• MalfunctionDec 19, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT WHEN USING BD VACUTAINER® SERUM PLUS BLOOD COLLECTION TUBES, HEMOLYSIS WAS OBSERVED IN THE SPECIMEN OF 2 DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENTS OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849015 ↗
• MalfunctionDec 11, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23779756 ↗
• MalfunctionDec 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM PLUS BLOOD COLLECTION TUBES, THE CAPS OF THREE TUBES WERE LOOSE. IN ONE INSTANCE, THE CAP CAME OFF DURING INVERSION AND MIXING, RESULTING IN EXPOSURE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: Exposure to Body Fluids; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778631 ↗
• MalfunctionNov 12, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  REPORT 1 OF 3: IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM PLUS BLOOD COLLECTION TUBES, WHITE SPECKS WERE SEEN INSIDE OF AN UNSPECIFIED NUMBER OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536784 ↗
• MalfunctionNov 12, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  REPORT 2 OF 3. IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM PLUS BLOOD COLLECTION TUBES, WHITE SPECKS WERE SEEN INSIDE OF AN UNSPECIFIED NUMBER OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536760 ↗
• MalfunctionNov 12, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  REPORT 3 OF 3: IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM PLUS BLOOD COLLECTION TUBES, WHITE SPECKS WERE SEEN INSIDE OF AN UNSPECIFIED NUMBER OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536759 ↗
• MalfunctionNov 10, 2025Separation Problem; Separation Problem

  REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM PLUS BLOOD COLLECTION TUBES, THE CAP OF AN UNSPECIFIED NUMBER OF TUBES BECOMES LOOSE AND COMES OFF. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511490 ↗
• MalfunctionNov 10, 2025Separation Problem; Separation Problem

  REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM PLUS BLOOD COLLECTION TUBES, THE CAP OF AN UNSPECIFIED NUMBER OF TUBES BECOMES LOOSE AND COMES OFF. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511485 ↗
• MalfunctionNov 4, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM PLUS BLOOD COLLECTION TUBES, A WHITE SPECK WAS SEEN INSIDE OF AN UNSPECIFIED NUMBER OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23468836 ↗
• MalfunctionNov 3, 2025Device Ingredient or Reagent Problem; Device Contamination with Chemical or Other Material; Device Ingredient or Reagent Problem; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM PLUS BLOOD COLLECTION TUBES, ABNORMAL WHITE ADDITIVE IS SEEN IN AN UNSPECIFIED NUMBER OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23455835 ↗
• MalfunctionAug 18, 2025Material Deformation; Material Deformation

  REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM PLUS BLOOD COLLECTION TUBES, THE CAP OF FIVE TUBES CANNOT BE RECAPPED PROPERLY, THE STOPPER WILL NOT SEAL. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22834160 ↗
• MalfunctionAug 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  REPORT 2 OF 2. IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM PLUS BLOOD COLLECTION TUBES, THE CAP OF FIVE TUBES CANNOT BE RECAPPED PROPERLY, THE STOPPER WILL NOT SEAL. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22834054 ↗
• MalfunctionJul 17, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO USING BD VACUTAINER® SERUM PLUS BLOOD COLLECTION TUBES, 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 22530597 ↗
• MalfunctionJun 25, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO USING PAXGENE® BLOOD RNA TUBE, ABNORMAL ADDITIVE WAS SEEN IN 20 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329777 ↗
• MalfunctionJun 12, 2025Difficult to Insert; Device Contamination with Chemical or Other Material; Difficult to Insert; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM PLUS BLOOD COLLECTION TUBES, IT IS DIFFICULT TO PIERCE THROUGH THE STOPPER OF AN UNSPECIFIED NUMBER OF TUBES RESULTING IN CORING AND SMALL PIECES OF RUBBER ENTERING THE TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22195564 ↗
• MalfunctionJun 5, 2025Crack; Crack

  IT WAS REPORTED THAT PRIOR TO USING BD VACUTAINER® SERUM PLUS BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES WERE CRACKED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22152392 ↗
• MalfunctionMay 14, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  REPORT 3 OF 4: IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM PLUS BLOOD COLLECTION TUBES, 12 TUBES EXHIBITED ADDITIVE ABNORMALITY. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022609 ↗
• MalfunctionMay 14, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  REPORT 4 OF 4: IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM PLUS BLOOD COLLECTION TUBES, 10 TUBES EXHIBITED ADDITIVE ABNORMALITY. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022364 ↗
• MalfunctionMay 14, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  REPORT 2 OF 4: IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM PLUS BLOOD COLLECTION TUBES, 80 TUBES EXHIBITED ADDITIVE ABNORMALITY. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022363 ↗
• MalfunctionMay 14, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  REPORT 1 OF 4: IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM PLUS BLOOD COLLECTION TUBES, 23 TUBES EXHIBITED ADDITIVE ABNORMALITY. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022359 ↗
• MalfunctionApr 30, 2025Leak/Splash; Leak/Splash

  REPORT 1 OF 2 IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM PLUS BLOOD COLLECTION TUBES, STOPPER POP OFF WAS SEEN WITH ONE (1) TUBE RESULTING IN SAMPLE LEAKAGE DURING TRANSPORT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21935199 ↗
• MalfunctionApr 29, 2025Leak/Splash; Leak/Splash

  REPORT 2 OF 2. IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM PLUS BLOOD COLLECTION TUBES, STOPPER POP OFF WAS SEEN WITH TWO (2) TUBES RESULTING IN SAMPLE LEAKAGE DURING TRANSPORT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926592 ↗
• MalfunctionApr 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM PLUS BLOOD COLLECTION TUBES, THE COLOR OF AN UNSPECIFIED NUMBER OF TUBES APPEARED SLIGHTLY CLOUDY. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21864950 ↗

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.