BD Vacutainer® SST™ 367977Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 30382903679776), received between Nov 27, 2017 and Feb 26, 2026 — classified as 60 malfunctions.

The most frequently reported specific device problem is “Short Fill” (19 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, 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 24462480 ↗
• MalfunctionFeb 17, 2026Incorrect, Inadequate or Imprecise Result or Readings; Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, THERE WAS INADEQUATE VACUUM (VACUUM STOPS FILLING HALFWAY) AND ERRONEOUS RESULTS (NEGATIVE CA++ AND VERY HIGH K+). NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24365837 ↗
• MalfunctionFeb 2, 2026Material Deformation

  It was reported while using BD Vacutainer® SST¿, an unspecified number of tubes are bowed preventing the automated instrument from aspirating the sample properly. There was no health impact or consequences reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24235698 ↗
• MalfunctionJan 27, 2026Material Deformation

  IT WAS REPORTED PRIOR TO USING BD VACUTAINER® SST¿, THERE WERE AN UNSPECIFIED NUMBER OF TUBES WITH BENT TOPS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192564 ↗
• MalfunctionNov 10, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE THE TUBE PUSHED OFF THE COLLECTION DEVICE CAUSING BLOOD LEAKAGE IN AN UNSPECIFIED NUMBER OF DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510209 ↗
• MalfunctionNov 10, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE THE TUBE PUSHED OFF THE COLLECTION DEVICE CAUSING BLOOD LEAKAGE IN AN UNSPECIFIED NUMBER OF DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510058 ↗
• MalfunctionNov 3, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ THE TUBE PRESSURE IS HIGH LEADING TO THE THE TUBE PUSHING OFF THE NEEDLE AND LEAKAGE. THE ISSUE OCCURS IN AN UNSPECIFIED NUMBER OF DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23458389 ↗
• MalfunctionOct 30, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿, AN UNSPECIFIED NUMBER OF DEVICES ARE BENT AND THEREFORE CANNOT BE PUT ON THE ANALYZER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425383 ↗
• MalfunctionOct 20, 2025Material Deformation; Material Deformation

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, AN UNSPECIFIED NUMBER OF TUBES WERE DISCOVERED TO BE BENT POST COLLECTION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23343279 ↗
• MalfunctionFeb 3, 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 21294124 ↗
• MalfunctionJan 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 4 OF 8 IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE CUSTOMER RECEIVED ERRONEOUS RESULTS FOR SODIUM AND OTHER UNNAMED CHEMISTRY ASSAYS. THE SAMPLE WAS RETESTED MULTIPLE TIMES AND CONTINUED TO GIVE HIGHER VALUES. THE PATIENT WAS SENT TO THE EMERGENCY ROOM. UPON RECOLLECTION AND RETESTING THE RESULTS WERE NORMAL. THE INITIAL RESULTS WERE AMENDED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21179441 ↗
• MalfunctionJan 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 8 OF 8 IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE CUSTOMER RECEIVED ERRONEOUS RESULTS FOR SODIUM AND OTHER UNNAMED CHEMISTRY ASSAYS. THE SAMPLE WAS RETESTED MULTIPLE TIMES AND CONTINUED TO GIVE HIGHER VALUES. THE PATIENT WAS SENT TO THE EMERGENCY ROOM. UPON RECOLLECTION AND RETESTING THE RESULTS WERE NORMAL. THE INITIAL RESULTS WERE AMENDED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21179348 ↗
• MalfunctionJan 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 5 OF 8: IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE CUSTOMER RECEIVED ERRONEOUS RESULTS FOR SODIUM AND OTHER UNNAMED CHEMISTRY ASSAYS. THE SAMPLE WAS RETESTED MULTIPLE TIMES AND CONTINUED TO GIVE HIGHER VALUES. THE PATIENT WAS SENT TO THE EMERGENCY ROOM. UPON RECOLLECTION AND RETESTING THE RESULTS WERE NORMAL. THE INITIAL RESULTS WERE AMENDED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21179346 ↗
• MalfunctionJan 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 6 OF 8. IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE CUSTOMER RECEIVED ERRONEOUS RESULTS FOR SODIUM AND OTHER UNNAMED CHEMISTRY ASSAYS. THE SAMPLE WAS RETESTED MULTIPLE TIMES AND CONTINUED TO GIVE HIGHER VALUES . THE PATIENT WAS SENT TO THE EMERGENCY ROOM. UPON RECOLLECTION AND RETESTING THE RESULTS WERE NORMAL. THE INITIAL RESULTS WERE AMENDED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21179343 ↗
• MalfunctionJan 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 7 OF 8: IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE CUSTOMER RECEIVED ERRONEOUS RESULTS FOR SODIUM AND OTHER UNNAMED CHEMISTRY ASSAYS. THE SAMPLE WAS RETESTED MULTIPLE TIMES AND CONTINUED TO GIVE HIGHER VALUES. THE PATIENT WAS SENT TO THE EMERGENCY ROOM. UPON RECOLLECTION AND RETESTING THE RESULTS WERE NORMAL. THE INITIAL RESULTS WERE AMENDED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21179342 ↗
• MalfunctionJan 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 2 OF 8. IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE CUSTOMER RECEIVED ERRONEOUS RESULTS FOR SODIUM AND OTHER UNNAMED CHEMISTRY ASSAYS. THE SAMPLE WAS RETESTED MULTIPLE TIMES AND CONTINUED TO GIVE HIGHER VALUES. THE PATIENT WAS SENT TO THE EMERGENCY ROOM. UPON RECOLLECTION AND RETESTING THE RESULTS WERE NORMAL. THE INITIAL RESULTS WERE AMENDED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21179340 ↗
• MalfunctionJan 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT 3 OF 8. IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE CUSTOMER RECEIVED ERRONEOUS RESULTS FOR SODIUM AND OTHER UNNAMED CHEMISTRY ASSAYS. THE SAMPLE WAS RETESTED MULTIPLE TIMES AND CONTINUED TO GIVE HIGHER VALUES. THE PATIENT WAS SENT TO THE EMERGENCY ROOM. UPON RECOLLECTION AND RETESTING THE RESULTS WERE NORMAL. THE INITIAL RESULTS WERE AMENDED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21179339 ↗
• MalfunctionJan 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORT OF 8. IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE CUSTOMER RECEIVED ERRONEOUS RESULTS FOR SODIUM AND OTHER UNNAMED CHEMISTRY ASSAYS. THE SAMPLE WAS RETESTED MULTIPLE TIMES AND CONTINUED TO GIVE HIGHER VALUES. THE PATIENT WAS SENT TO THE EMERGENCY ROOM. UPON RECOLLECTION AND RETESTING THE RESULTS WERE NORMAL. THE INITIAL RESULTS WERE AMENDED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21179211 ↗
• MalfunctionAug 23, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES THAT THERE WAS INCOMPLETE SERUM SEPARATION ON 2 PATIENT SAMPLES. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20050791 ↗
• MalfunctionJun 14, 2024Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE TUBES WERE UNDERFILLING. THERE WAS NO REPORT OF IMPACT TO THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19538399 ↗
• MalfunctionApr 5, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE WITH THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE STOPPER CAME OUT OF A TUBE WHILE IN THE CENTRIFUGE AND CAUSED BLOOD LEAKAGE. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19050193 ↗
• MalfunctionAug 21, 2023Inability to Auto-Fill; Difficult to Insert; Inability to Auto-Fill; Difficult to Insert

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES THAT THERE WAS UNDERFILL OR LOW DRAW AND TUBE PUSH OFF. THIS OCCURRED 22 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING PRODUCT 367977 LOT NO. 2306642 UNABLE TO DRAW OR STAY ON THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17591990 ↗
• MalfunctionJul 31, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT THERE HAVE BEEN BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE ISSUES 30% OF SAMPLES HEMOLYZED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTING 30% OF SAMPLES HEMOLYZED FOR PRODUCT 367977.

  Patient problems: Insufficient Information

  MAUDE report 17427915 ↗
• MalfunctionDec 27, 2022Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES IS LOOSING SUCTION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "IT WAS REPORTED BY THE CUSTOMER THAT TUBES ARE LOOSING SUCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16052021 ↗
• MalfunctionDec 9, 2022Material Deformation; Material Deformation

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED MOLDING DEFECT (SHORT SHOT). THIS EVENT OCCURRED ONCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "CUSTOMER STATES TUBE IS CURVED AT TOP CAUSING PIPETTING ERRORS ON INSTRUMENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15951363 ↗

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.