BD Vacutainer® SST™ II Advance 366444Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 50382903664448), received between Apr 13, 2018 and May 12, 2025 — classified as 34 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); 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2025Short Fill; Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE, 100 TUBES WERE UNDERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22006768 ↗
• MalfunctionApr 14, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT DURING USE WITH BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES THERE WAS INSUFFICIENT CLOT ACTIVATOR ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER INQUIRY: CUSTOMER IS REPORTING 6ML SST VACUTAINER TUBES HAVE INCOMPLETE CLOTTING WITH HEALTHY PATIENTS. FROM PIERIS PHARMACEUTICAL INC. PERFORMING CLINICAL TRIALS USING 6ML SST2 TUBES. LAB VALIDATED AN ASSAY WHERE THE TUBES ARE ALLOWED TO CLOT FOR 30-60 MINUTES ON WET ICE AND THEN SPUN DOWN IN A REFRIGERATED CENTRIFUGE. SAMPLES ARE COLLECTED, INVERTED 5 TIMES, ALLOWED TO CLOT, AND THEN CENTRIFUGED. LAB IS FINDING LARGE "HUNKS" OF FIBRIN IN THE SERUM AND SEEING INCOMPLETE CLOTTING. LAB IS TELLING THE SITES TO RE-SPIN THE TUBES AND THEN RUN THE SAMPLE. CUSTOMER IS INQUIRING WHAT WOULD CAUSE THE INCOMPLETE SEPARATION AND THE GELATINOUS MATERIAL IN THE SERUM CUSTOMER IS REPORTING 6ML SST VACUTAINER TUBES HAVE INCOMPLETE CLOTTING WITH HEALTHY PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16747912 ↗
• MalfunctionApr 14, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT DURING USE WITH 4 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES THERE WAS A LOW DRAW. RECOLLECTION WAS NOT PERFORMED. PATIENT 8 OF 11. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SITE HAS EXPRESSED CONCERN THAT THE BLOOD DRAW IS SLOWER THAN EXPECTED AND THAT THE TOTAL SAMPLE VOLUME IS INCONSISTENT. THIS IS RESULTING IN QUANTITIES OF PLASMA INSUFFICIENT FOR THE ALIQUOTTING REQUIRED FOR THE PROTOCOL. VARIABLE TOTAL VOLUME OBTAINED RESULTED IN FULL ALLOCATION OF SERUM ALIQUOTS NOT BEING ABLE TO BE COMPLETED. THUS, LESS SAMPLES AVAILABLE FOR ANALYSIS THAN ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16744602 ↗
• MalfunctionApr 14, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT DURING USE WITH 4 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES THERE WAS A LOW DRAW. RECOLLECTION WAS NOT PERFORMED. PATIENT 11 OF 11. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SITE HAS EXPRESSED CONCERN THAT THE BLOOD DRAW IS SLOWER THAN EXPECTED AND THAT THE TOTAL SAMPLE VOLUME IS INCONSISTENT. THIS IS RESULTING IN QUANTITIES OF PLASMA INSUFFICIENT FOR THE ALIQUOTTING REQUIRED FOR THE PROTOCOL. VARIABLE TOTAL VOLUME OBTAINED RESULTED IN FULL ALLOCATION OF SERUM ALIQUOTS NOT BEING ABLE TO BE COMPLETED. THUS, LESS SAMPLES AVAILABLE FOR ANALYSIS THAN ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16744601 ↗
• MalfunctionApr 14, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT DURING USE WITH 4 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES THERE WAS A LOW DRAW. RECOLLECTION WAS NOT PERFORMED. PATIENT 7 OF 11. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SITE HAS EXPRESSED CONCERN THAT THE BLOOD DRAW IS SLOWER THAN EXPECTED AND THAT THE TOTAL SAMPLE VOLUME IS INCONSISTENT. THIS IS RESULTING IN QUANTITIES OF PLASMA INSUFFICIENT FOR THE ALIQUOTTING REQUIRED FOR THE PROTOCOL. VARIABLE TOTAL VOLUME OBTAINED RESULTED IN FULL ALLOCATION OF SERUM ALIQUOTS NOT BEING ABLE TO BE COMPLETED. THUS, LESS SAMPLES AVAILABLE FOR ANALYSIS THAN ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16744363 ↗
• MalfunctionApr 14, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT DURING USE WITH 4 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES THERE WAS A LOW DRAW. RECOLLECTION WAS NOT PERFORMED. PATIENT 5 OF 11 THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SITE HAS EXPRESSED CONCERN THAT THE BLOOD DRAW IS SLOWER THAN EXPECTED AND THAT THE TOTAL SAMPLE VOLUME IS INCONSISTENT. THIS IS RESULTING IN QUANTITIES OF PLASMA INSUFFICIENT FOR THE ALIQUOTTING REQUIRED FOR THE PROTOCOL. VARIABLE TOTAL VOLUME OBTAINED RESULTED IN FULL ALLOCATION OF SERUM ALIQUOTS NOT BEING ABLE TO BE COMPLETED. THUS, LESS SAMPLES AVAILABLE FOR ANALYSIS THAN ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16744354 ↗
• MalfunctionApr 14, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT DURING USE WITH 4 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES THERE WAS A LOW DRAW. RECOLLECTION WAS NOT PERFORMED. PATIENT 10 OF 11. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SITE HAS EXPRESSED CONCERN THAT THE BLOOD DRAW IS SLOWER THAN EXPECTED AND THAT THE TOTAL SAMPLE VOLUME IS INCONSISTENT. THIS IS RESULTING IN QUANTITIES OF PLASMA INSUFFICIENT FOR THE ALIQUOTTING REQUIRED FOR THE PROTOCOL. VARIABLE TOTAL VOLUME OBTAINED RESULTED IN FULL ALLOCATION OF SERUM ALIQUOTS NOT BEING ABLE TO BE COMPLETED. THUS, LESS SAMPLES AVAILABLE FOR ANALYSIS THAN ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16744353 ↗
• MalfunctionApr 14, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT DURING USE WITH 4 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES THERE WAS A LOW DRAW. RECOLLECTION WAS NOT PERFORMED. PATIENT 4 OF 11. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SITE HAS EXPRESSED CONCERN THAT THE BLOOD DRAW IS SLOWER THAN EXPECTED AND THAT THE TOTAL SAMPLE VOLUME IS INCONSISTENT. THIS IS RESULTING IN QUANTITIES OF PLASMA INSUFFICIENT FOR THE ALIQUOTTING REQUIRED FOR THE PROTOCOL. VARIABLE TOTAL VOLUME OBTAINED RESULTED IN FULL ALLOCATION OF SERUM ALIQUOTS NOT BEING ABLE TO BE COMPLETED. THUS, LESS SAMPLES AVAILABLE FOR ANALYSIS THAN ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16744350 ↗
• MalfunctionApr 14, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT DURING USE WITH 4 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES THERE WAS A LOW DRAW. RECOLLECTION WAS NOT PERFORMED. PATIENT 9 OF 11 THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SITE HAS EXPRESSED CONCERN THAT THE BLOOD DRAW IS SLOWER THAN EXPECTED AND THAT THE TOTAL SAMPLE VOLUME IS INCONSISTENT. THIS IS RESULTING IN QUANTITIES OF PLASMA INSUFFICIENT FOR THE ALIQUOTTING REQUIRED FOR THE PROTOCOL. VARIABLE TOTAL VOLUME OBTAINED RESULTED IN FULL ALLOCATION OF SERUM ALIQUOTS NOT BEING ABLE TO BE COMPLETED. THUS, LESS SAMPLES AVAILABLE FOR ANALYSIS THAN ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16744338 ↗
• MalfunctionApr 14, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT DURING USE WITH 4 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES THERE WAS A LOW DRAW. RECOLLECTION WAS NOT PERFORMED. PATIENT 2 OF 11. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SITE HAS EXPRESSED CONCERN THAT THE BLOOD DRAW IS SLOWER THAN EXPECTED AND THAT THE TOTAL SAMPLE VOLUME IS INCONSISTENT. THIS IS RESULTING IN QUANTITIES OF PLASMA INSUFFICIENT FOR THE ALIQUOTTING REQUIRED FOR THE PROTOCOL. VARIABLE TOTAL VOLUME OBTAINED RESULTED IN FULL ALLOCATION OF SERUM ALIQUOTS NOT BEING ABLE TO BE COMPLETED. THUS, LESS SAMPLES AVAILABLE FOR ANALYSIS THAN ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16744337 ↗
• MalfunctionApr 14, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT DURING USE WITH 4 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES THERE WAS A LOW DRAW. RECOLLECTION WAS NOT PERFORMED. PATIENT 6 OF 11. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SITE HAS EXPRESSED CONCERN THAT THE BLOOD DRAW IS SLOWER THAN EXPECTED AND THAT THE TOTAL SAMPLE VOLUME IS INCONSISTENT. THIS IS RESULTING IN QUANTITIES OF PLASMA INSUFFICIENT FOR THE ALIQUOTING REQUIRED FOR THE PROTOCOL. VARIABLE TOTAL VOLUME OBTAINED RESULTED IN FULL ALLOCATION OF SERUM ALIQUOTS NOT BEING ABLE TO BE COMPLETED. THUS, LESS SAMPLES AVAILABLE FOR ANALYSIS THAN ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16744332 ↗
• MalfunctionApr 14, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT DURING USE WITH 4 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES THERE WAS A LOW DRAW. RECOLLECTION WAS NOT PERFORMED. PATIENT 3 OF 11. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SITE HAS EXPRESSED CONCERN THAT THE BLOOD DRAW IS SLOWER THAN EXPECTED AND THAT THE TOTAL SAMPLE VOLUME IS INCONSISTENT. THIS IS RESULTING IN QUANTITIES OF PLASMA INSUFFICIENT FOR THE ALIQUOTTING REQUIRED FOR THE PROTOCOL. VARIABLE TOTAL VOLUME OBTAINED RESULTED IN FULL ALLOCATION OF SERUM ALIQUOTS NOT BEING ABLE TO BE COMPLETED. THUS, LESS SAMPLES AVAILABLE FOR ANALYSIS THAN ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16744329 ↗
• MalfunctionApr 13, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT DURING USE WITH 4 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES THERE WAS A LOW DRAW. RECOLLECTION WAS NOT PERFORMED. PATIENT 1 OF 11. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SITE HAS EXPRESSED CONCERN THAT THE BLOOD DRAW IS SLOWER THAN EXPECTED AND THAT THE TOTAL SAMPLE VOLUME IS INCONSISTENT. THIS IS RESULTING IN QUANTITIES OF PLASMA INSUFFICIENT FOR THE ALIQUOTTING REQUIRED FOR THE PROTOCOL. VARIABLE TOTAL VOLUME OBTAINED RESULTED IN FULL ALLOCATION OF SERUM ALIQUOTS NOT BEING ABLE TO BE COMPLETED. THUS, LESS SAMPLES AVAILABLE FOR ANALYSIS THAN ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16740463 ↗
• MalfunctionDec 7, 2022Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE HAVE HAS SEVERAL SITES REPORT AN ISSUE WITH 6ML SST TUBE 366444 LOT 1326457, THE ISSUE IS THE AMOUNT OF PRESSURE/VACUUM WHEN USING 6ML SST TUBES FOR COLLECTING CHEMISTRY SAMPLES. WE HAVE HAD SOME SAMPLE CANCELLATIONS DUE TO INSUFFICIENT VOLUME BEING COLLECTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15934419 ↗
• MalfunctionNov 29, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ON (B)(6) 2021, WHEN THE BLOOD SAMPLE COLLECTION OF BIOLOGICAL SAMPLES FOR THE STUDY WAS CONDUCTED, IT WAS FOUND THAT THE NEGATIVE PRESSURE OF ALL BLOOD COLLECTION TUBES WAS INSUFFICIENT, THE BLOOD COLLECTION SPEED WAS SLOW, AND THE EXPECTED BLOOD COLLECTION VOLUME WAS NOT ACHIEVED, RESULTING IN INSUFFICIENT BLOOD VOLUME IN THE BACKUP TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12886535 ↗
• MalfunctionNov 10, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE ARE HAVING INSUFFICIENT DRAW PRESSURE." THIS IS REPORT (3 OF 3).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12789845 ↗
• MalfunctionJan 29, 2020Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED THAT BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES HAD BLOOD POOLING IN THE STOPPER WELL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "COMPLAINT CAME IN THROUGH A LAB TECHNICIAN WHO WORKS AT SEVERAL DIFFERENT ZNA SITES. SHE ALSO PERFORMS NIGHTLY BLOOD COLLECTIONS. SHE NOTICED BLOOD DROPS ON THE CLOSURE OF THE VACUTAINER TUBES (DIFFERENT TUBES, DIFFERENT LOT NUMBERS). THESE DROPS FOUL THE COLLECTION BAGS, USED TO TRANSPORT THE TUBES TO THE LAB (SEE PICTURE ATTACHED). ALSO, WHEN THE DROPS ARE DRIED, THE FALL OF ON THE TABLE IN THE LAB."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9644877 ↗
• MalfunctionDec 19, 2019Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED DURING BD TESTING, THE TUBES UNDER FILLED WITH A BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES. THIS OCCURRED WITH 26 SEPARATE TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AS PART OF CAPA (B)(4), WE SOURCED BD VACUTAINER® SST 5.0 ML (368970), 3.5 ML (368967) AND 6.0 ML (366444) TUBES WHICH WERE STERILIZED AT NOMINAL (~22.6 KGY) AND MAXIMUM DOSE LEVELS (~32.3 KGY) FOR DRAW VOLUME TESTING. THE TESTING INDICATES BOTH NOMINAL AND MAXIMUM DOSED BD VACUTAINER® SST 5.0, 3.5 AND 6.0 ML TUBES DID NOT MEET THE PRODUCT SPECIFICATION FOR DRAW VOLUME OF -19% OF LABELLED DRAW AT BELOW MENTIONED TEST INTERVALS. IRRADIATION DOSE (KGY): NOMINAL 20.4-22.6 TEST INTERVAL (MONTHS): T=19.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9497262 ↗
• MalfunctionDec 18, 2019Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  MATERIAL NO: 366444 BATCH NO: 8036515. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES TESTING INDICATES BOTH NOMINAL AND MAXIMUM DOSED DID NOT MEET THE PRODUCT SPECIFICATION FOR DRAW VOLUME OF -19% OF LABELLED DRAW AT TEST INTERVALS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AS PART OF CAPA (B)(4), WE SOURCED BD VACUTAINER® SST 5.0 ML (368970), 3.5 ML (368967) AND 6.0 ML (366444) TUBES WHICH WERE STERILIZED AT NOMINAL (~22.6 KGY) AND MAXIMUM DOSE LEVELS (~32.3 KGY) FOR DRAW VOLUME TESTING. THE TESTING INDICATES BOTH NOMINAL AND MAXIMUM DOSED BD VACUTAINER® SST 5.0, 3.5 AND 6.0 ML TUBES DID NOT MEET THE PRODUCT SPECIFICATION FOR DRAW VOLUME OF -19% OF LABELLED DRAW AT BELOW MENTIONED TEST INTERVALS. PLEASE REFER BELOW GRAPHS FOR DETAILS. IRRADIATION DOSE (KGY): MAXIMUM 30.6-31.7. TEST INTERVAL (MONTHS): T=19.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9490596 ↗
• MalfunctionJul 18, 2019Leak/Splash; Gas/Air Leak; Leak/Splash; Gas/Air Leak

  IT WAS REPORTED THAT A DENTED TUBE WAS FOUND DURING USE WITH A BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DENTED SSTII ADVANCE TUBE. THE TUBE ARRIVED IN THE LAB. A NEW TUBE WAS DRAWN. ONLY ONE TUBE AFFECTED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8804227 ↗
• MalfunctionMay 1, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BEFORE USE OF THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES SOME OF THE TUBES IN THE LOT A GEL-LIKE SUBSTANCE ABOVE THE ACTUAL GEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GEL ISSUES IN SSTII: SOME TUBES OF THE LOT HAVE A GEL-LIKE SUBSTANCE ABOVE THE ACTUAL GEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8569106 ↗
• MalfunctionJan 11, 2019Short Fill; Short Fill

  IT WAS REPORTED THAT SIX BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES EXPERIENCED UNDER FILLING DURING USE.

  Patient problems: No Information

  MAUDE report 8241012 ↗
• MalfunctionDec 4, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BEFORE USE OF THE BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBES THE INNER RUBBER OF HEMOGARD STOPPER WAS LOOSE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8130901 ↗
• MalfunctionNov 9, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES WERE MISSING THE LABEL INFORMATION. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8054143 ↗
• MalfunctionJul 19, 2018Leak/Splash; Volume Accuracy Problem; Leak/Splash; Volume Accuracy Problem

  IT WAS REPORTED THAT THE STOPPER OF BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES WAS NOT SEATING PROPERLY CAUSING LOW DRAWS. NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7705226 ↗

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.