BD Vacutainer® SST™ II Advance 366882Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 50382903668828), received between Nov 27, 2017 and Feb 18, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Device Ingredient or Reagent Problem” (5 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE, 150 TUBES ACROSS THREE LOT NUMBERS DISPLAYED FIBRIN. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21405217 ↗
• MalfunctionApr 18, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES HAD FIBRIN PRESENT IN THE SAMPLE AFTER CENTRIFUGATION. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19133227 ↗
• MalfunctionJun 13, 2023Incorrect, Inadequate or Imprecise Result or Readings; Device Ingredient or Reagent Problem; Incorrect, Inadequate or Imprecise Result or Readings; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES CUSTOMER STATED THAT TUBES ARE COATED WITH CLOT ACTIVATOR AND GEL AT THE BOTTOM AND UP THE SIDE OF THE TUBES. THERE ARE VERY 'LARGE' 'LUMPS' OF GEL AND CLOT ACTIVATOR ON THE SIDE OF THE TUBES AND 'TONGUES' OF GEL UP THE SIDE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE "IT CONCERNS THE BD SSTTM II ADVANCE (SERUM WITH GEL) TUBE TYPE AND THE FOLLOWING LOT NUMBERS HAVE BEEN EXAMINED, 2203591, 2245739, 2311301, 2283470 AND 2175165. BD'S TUBES ARE COATED WITH CLOT ACTIVATOR AND GEL AT THE BOTTOM AND UP THE SIDE OF THE TUBES. THERE ARE VERY 'LARGE' 'LUMPS' OF GEL AND CLOT ACTIVATOR ON THE SIDE OF THE TUBES AND 'TONGUES' OF GEL UP THE SIDE. THERE ARE IS IN COMPARISON WITH OTHER MANUFACTURER'S SIMILAR TUBE TYPES NOT VISIBLE SPRAY / LUMPS OF GEL AND CLOT ACTIVATOR OR 'TONGUES' OF GEL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17121515 ↗
• MalfunctionDec 30, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES HAS FOUND WHITE RESIDUE IN THE TUBE. THIS EVENT OCCURRED 100 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "SOME OF THE SST TUBES THAT WE HAVE IN STOCK HAVE GOT WHITE RESIDUE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16078056 ↗
• MalfunctionJul 14, 2022Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES GEL HAS TURNED INTO LIQUID IN THE SST TUBE. THIS EVENT OCCURRED 100 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ¿GEL HAS TURNED INTO LIQUID IN THE SST TUBES¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15018754 ↗
• MalfunctionJul 7, 2022Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBE THERE WAS POOR BARRIER SEPARATION OF SAMPLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WAS "A PROBLEM WITH GEL MIGRATION IN THE GREEN TUBES AND ONCE ON DRY TUBES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14951033 ↗
• MalfunctionJun 30, 2022Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES A PROBLEM WITH GEL MIGRATION IN GREEN TUBES AND ONCE ON DRY TUBES. ASKS IF THIS IS DUE TO THE DENSITY OF THE SERUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ¿WOULD LIKE TO CONTACT YOU ABOUT A PROBLEM WITH GEL MIGRATION IN GREEN TUBES AND ONCE ON DRY TUBES. ASKS IF THIS IS DUE TO THE DENSITY OF THE SERUM. CONSEQUENCES: RE-COLLECTED PATIENT AND SIGNIFICANT CONSEQUENCES ON THE PROPER FUNCTIONING OF BIOCHEMISTRY EQUIPMENT: SAMPLE COLLECTION NEEDLE BLOCKED BY GEL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14880655 ↗
• MalfunctionApr 29, 2022Overfill; Overfill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED OVERFILL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WE ARE EXPERIENCING RIGHT NOW THAT THE YELLOW GLASSES WE USE ARE OVERFILLED. NORMALLY THERE IS A VACCINE WHICH CAUSES THEM TO AUTOMATICALLY STOP DRAWING BLOOD, BUT IT IS AS IF THERE IS AN INCREASED VACCINE SO THAT THEY BECOME OVERFILLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14251283 ↗
• MalfunctionFeb 25, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES THERE WAS UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT OCCURRED TWICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "NURSE WAS UNABLE TO DRAW BLOOD FROM A PATIENT DUE TO FACT THAT THE TUBES WERE NOT FILLING. SHE TRIED WITH 2 TUBES FROM THE SAME LOT, BUT IT STILL DID NOT WORK. THE NURSE SAID SHE WAS ABLE TO FIND A GREAT VEIN BUT THE SUCTION OF THE TUBE WAS NOT WORKING. ONCE SHE REALIZED SHE WASN¿T GOING TO GET BLOOD INTO THE SECOND TUBE, SHE TOOK THE NEEDLE OUT OF THE PATIENTS ARM AND BLOOD GUSHED DOWN HIS ARM ENSURING THAT SHE DID HAVE A GREAT VEIN. SHE STRONGLY BELIEVES IT IS THE FUNCTION OF THE TUBES. THE LAST NURSE ALSO BELIEVED IT WAS THE FUNCTION OF THE TUBES."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11379899 ↗
• MalfunctionJan 26, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES UNDERFILLED. "I'M WRITING THIS EMAIL BECAUSE WE HAVE A PROBLEM WITH THE 2.5 ML SST TUBES OF REFERENCE 366882. WE HAVE ENCOUNTERED 4 TIMES SINCE MONDAY. THE LOT CONCERNED IS 0196960 AND WE HAVE 5800 UNITS. COULD YOU PLEASE FORWARD THIS CONCERN TO WHOEVER IS ENTITLED AND SEE IF ANOTHER LOT WOULD BE AVAILABLE. IF SO, WE WOULD LIKE TO MAKE AN EXCHANGE. I THANK YOU IN ADVANCE AND LOOK FORWARD TO YOUR RETURN." JAN 12, WE ARE CURRENTLY STUDYING TO SEE IF THIS IS INDEED DUE TO UNDERFILLING. TO DATE WE HAVE HAD NO NEW INCIDENTS. I WILL GET BACK TO YOU IF WE HAVE ANY FURTHER PROBLEMS WITH THIS BATCH."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11230702 ↗
• MalfunctionDec 18, 2019Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED THAT THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE EXPERIENCED BLOOD POOLING IN THE STOPPER WELL DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLOOD POOLING IN SSTII 2,5 ML 366882 WITH LOT 9128593. DURING A BLOOD COLLECTION IN THE HOSPITAL, BLOOD POOLING WAS NOTICED IN THE SSTII 2,5 ML TUBE 366882 WITH LOT NUMBER 91285593. THIS BLOOD DROPLET CAME LOOSE FROM THE STOPPER WHICH CAUSES THE RISK OF BLOOD CONTACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9489812 ↗
• MalfunctionNov 21, 2019Leak/Splash; Device Contamination with Body Fluid; Leak/Splash; Device Contamination with Body Fluid

  IT WAS REPORTED THAT BLOOD POOLING OCCURRED DURING USE WITH A BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "BLOOD POOLING IN STOPPER OF SSTII 2,5ML 366882 LOT 9128593 IN COMBO WITH PB UTW 23G 367364. A SSTII 2,5ML 366882 LOT 9128593 SHOWED BLOOD POOLING IN THE HEMOGARD STOPPER WHEN FILLED WITH THE PB UTW 23G 367364 LOT 9011664. THIS TUBE WAS THE 4TH IN THE DRAWN ORDER. UPON MIXING THE TUBE THE BLOOD IN THE STOPPER GETS LOOSE AND FALLS ON THE PATIENT'S CLOTHES, THE NURSE'S APRON AND THE PHLEBOTOMY TROLLEY (SPLATTER). THIS ALREADY HAPPENED BEFORE BUT WAS NOT COMMUNICATED TO BD."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9356362 ↗
• MalfunctionJan 31, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BLOOD REMAINED ON THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE WALL AND IN THE SERUM AFTER CENTRIFUGATION, WHICH CAUSED A "FALSE POSITIVE RESULT IN IMMUNOLOGY".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8294388 ↗
• MalfunctionJun 14, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES HAD THE WRONG COLORED CAP. NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO REPORT OF BLOOD EXPOSURE TO MUCOUS MEMBRANE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7603555 ↗
• MalfunctionJun 7, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES HAD FOREIGN MATTER IN THEM. NO SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7578436 ↗
• MalfunctionJun 5, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES HAD LABEL FLAWS. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7568957 ↗
• MalfunctionJan 22, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE CAP OF A BD VACUTAINER® SSTTM II TUBE WITH HEMOGARD¿ CLOSURE POPPED OFF DURING CENTRIFUGATION. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7210504 ↗
• MalfunctionDec 4, 2017Break; Detachment Of Device Component

  IT WAS REPORTED THAT STOPPER CREEPOUT/POPOFF OCCURRED WITH THE BD VACUTAINER® SST¿ II ADVANCE TUBES DURING PNEUMATIC TRANSPORT AND WHILE RESTING ON A TABLE. NO INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7079363 ↗
• MalfunctionNov 27, 2017Break

  IT WAS REPORTED THAT "BD VACUTAINER® SSTTM II ADVANCE TUBE HAD A BROKEN CAP. NO SERIOUS INJURY, NO MEDICAL INTERVENTIONS. PROBLEM WAS NOTICED BEFORE USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7058890 ↗

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.