BD Vacutainer® SST™ 367985Recalls & reported problems

Summary

The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 30382903679851), received between Nov 29, 2017 and Sep 30, 2026 — classified as 102 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (27 reports).

3 other recalls cover devices cleared under the same FDA submission (BK050036, K230855); 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 102 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952596 ↗
• MalfunctionSep 22, 2026Short Fill

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50861490 ↗
• MalfunctionSep 15, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50782014 ↗
• MalfunctionSep 15, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50781982 ↗
• MalfunctionApr 9, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED AFTER USING BD VACUTAINER® SST¿ 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 24835180 ↗
• MalfunctionApr 9, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ 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 24832411 ↗
• MalfunctionMar 9, 2026Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, 30 TUBES EXHIBITED INSUFFICIENT VACUUM. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24546286 ↗
• MalfunctionFeb 18, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, PIECES OF POLYSTYRENE 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 24378835 ↗
• MalfunctionJan 8, 2026Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT PRIOR TO USING BD VACUTAINER® SST¿, AIR BUBBLES WERE SEEN IN THE GEL 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 24011050 ↗
• MalfunctionJan 8, 2026Device Ingredient or Reagent Problem

  REPORT 3 OF 3 IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, ADDITIVE ABNORMALITIES PRESENTING AS WHITE PARTICLES ARE 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 24010452 ↗
• MalfunctionJan 8, 2026Device Ingredient or Reagent Problem

  REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, ADDITIVE ABNORMALITIES PRESENTING AS WHITE PARTICLES ARE 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 24010451 ↗
• MalfunctionJan 8, 2026Device Ingredient or Reagent Problem

  REPORT 2 OF 3: IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, ADDITIVE ABNORMALITIES PRESENTING AS WHITE PARTICLES ARE 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 24010449 ↗
• MalfunctionJan 8, 2026Device Ingredient or Reagent Problem

  REPORT 1 OF 3. IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, ADDITIVE ABNORMALITIES PRESENTING AS WHITE PARTICLES ARE 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 24010438 ↗
• MalfunctionJan 8, 2026Device Ingredient or Reagent Problem

  REPORT 2 OF 2. IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, ADDITIVE ABNORMALITIES PRESENTING AS WHITE PARTICLES ARE 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 24010437 ↗
• MalfunctionDec 9, 2025Short Fill; Device Contamination with Chemical or Other Material; Short Fill; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, FOUR TUBES UNDERFILLED AND ONE TUBE EXHIBITED FOREIGN MATTER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23761955 ↗
• MalfunctionNov 20, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, POOR GEL SEPARATION WAS SEEN WITH 10 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610420 ↗
• MalfunctionNov 19, 2025Fracture; Fracture

  REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, AN UNSPECIFIED NUMBER OF TUBES BURST DURING CENTRIFUGATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597906 ↗
• MalfunctionNov 19, 2025Fracture; Fracture

  REPORT 1 OF 2. IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, AN UNSPECIFIED NUMBER OF TUBES BURST DURING CENTRIFUGATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597903 ↗
• MalfunctionOct 20, 2025Fracture; Fracture

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, AN UNSPECIFIED NUMBER OF TUBES BREAK DURING CENTRIFUGATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23343283 ↗
• MalfunctionSep 4, 2025Short Fill; Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. ADDITIONALLY, A NON-REPORTABLE DEFECT OF COLLAPSED TUBES WAS ALSO 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 22965807 ↗
• MalfunctionAug 14, 2025Short Fill; Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22809226 ↗
• MalfunctionJun 17, 2025Short Fill; Short Fill

  IT WAS REPORTED AFTER USING BD VACUTAINER® SST¿, 27 TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22247487 ↗
• MalfunctionJun 5, 2025Short Fill; Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22153731 ↗
• MalfunctionJun 5, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SST¿, LIPOUT WAS SEEN WITH NINE TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22152397 ↗
• MalfunctionMay 14, 2025Short Fill; Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, TWO (2) TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019285 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under BK050036, K230855. 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.