BD Vacutainer® SST™ 367981Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 30382903679813), received between Dec 7, 2017 and May 10, 2022 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Short Fill” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 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 16, 2026.

Recalls naming this device

1. May 25, 2022Open, Classified

   Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

   Z-1618-2022 · Root cause: Environmental control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 10, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES ERRONEOUS RESULTS WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "CUSTOMER REPORTS ERRONEOUS RESULTS IN SST, PST AND RST TUBES. THIS ISSUE WAS REPORTED BY NADIA AYALA-LOPEZ IN A 2021 ARTICLE IN CLINICAL CHEMICAL ACTA."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14349911 ↗
• MalfunctionApr 19, 2022Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ 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: " DRAW VOLUME IS NOT DRAWING BLOOD PROPERLY. MANY OF THE TIGER TOPS ARE DUDS AND NOT DRAWING BLOOD. EITHER THE VACUTAINER NEEDLE ISN'T LONG ENOUGH OR THE RUBBER TOP IS TOO DEEP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14147788 ↗
• MalfunctionMar 18, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED POOR SEPARATOR MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WE ARE HAVING AN ISSUE WHERE THE BLOOD IS NOT SPINNING ALL THE WAY DOWN WITHIN THE TIME LIMIT/SETTINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13808674 ↗
• MalfunctionMar 1, 2022Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED POOR BARRIER SEPARATION OF SAMPLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT THE SERUM OR CLOT IS NOT SEPARATING OUT VERY NICELY. CUSTOMER TRIED TAKING MULTIPLE SAMPLES FROM DIFFERENT ANIMALS AND COMPARED THEM TO A COMPETITOR TUBE AS WELL. ITEM STILL FAILED TO SEPARATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13641718 ↗
• MalfunctionMar 11, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THE BD VACUTAINER¿ SST" BLOOD COLLECTION TUBES EXPERIENCED STOPPER POPS OUT OF THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "DR. THINKS THAT THERE IS SOMETHING DIFFERENT IN THE MAKEUP OF THE STOPPER BECAUSE THEY PUSH BACK OFF THE NEEDLE NOW. ITLL FLY BACK OFF THE NEEDLE. SOMETIMES WELL SEND IT THROUGH A CENTRIFUGE AND IT GETS HOT AND GET STUCK IN THERE. ITS ALMOST LIKE [THE STOPPER IS] MADE UP OF A DIFFERENT RUBBER. ALMOST LIKE THE RUBBER IS TOO THICK. THE RUBBER IS STICKY. RECEIVED FIRST CONTAINER OF THESE SPECIFIC TUBES 1-2 MONTHS AGO. COME IN A PACK OF 100 AND IT IS HAPPENING TO ALL TUBES. INCIDENT START DATE: UNKNOWN " ADDITIONAL INFORMATION RECEIVED 2/22/2021: "SPOKE WITH DR. (B)(6) ON FRIDAY (B)(6) 2021 6:00PM. HE SAID HE WOULD LIKE TO SEE MORE SPACE ON THE LABELS TO BE ABLE TO ENTER MORE OF THEIR INFORMATION. IN ADDITION TO THE LABEL SUGGESTION, HE ALSO STATED THAT THE STOPPER ON BD VACUTAINER TUBE 367981 SEEMS TO BE WORKING DIFFERENT FROM WHAT HE IS USED TO. WHEN ACCESSING A VEIN, HE SAID THE TUBE IS POPPING OFF OF THE NEEDLE AND HE HAS TO PUSH IT BACK ON AND HOLD IT. HE ALSO SAID THE STOPPER SEEMS TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11461932 ↗
• MalfunctionJan 18, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES EXPERIENCED POOR BARRIER SEPARATION OF SAMPLE. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE RED CELLS DO NOT SEPARATE FROM THE SERUM AFTER BEING SPUN DOWN, ALSO TUBES APPEAR TO HAVE SOMETHING CLEAR AND SOLID INSIDE (FIBRIN). THIS IS THE SECOND BATCH OF THESE WHERE THE RBC DO NOT SEPARATE FROM THE SERUM DURING SPIN DOWN PROCESS - OR IT SEPARATES, BUT NOT FULLY. CUSTOMER HAS ALREADY REPORTED ANOTHER BATCH AND HAS NO RESOLUTION FROM VENDOR. CUSTOMER IS FRUSTRATED AS NO OTHER BRAND OF THESE IS ON THE MARKET. SAYS THERE APPEARS TO BE SOMETHING CLEAR AND SOLID ON THE INSIDE OF THE TUBES THAT WAS NOT PRESENT WITH THE BRAND THEY USED TO USE." ON (B)(6) 2020 SPOKE WITH THE CUSTOMER, AND THE FACILITY TESTS HORSE BLOOD. THEY SWITCHED FROM ANOTHER COMPANY TO THE BD SST TUBES AND ARE GETTING BIG FIBRIN CLOTS AFTER CENTRIFUGATION. SHE DOES NOT KNOW THE SPEED OR TIME, AS SHE DOES NOT WORK IN THE LAB. I EXPLAINED THAT THESE TUBES ARE FOR HUMAN BLOOD, AND EXPLAINED THE HANDLING AND PROCESSING STEPS, AND STATED THAT WE DO NOT HAVE ANY DATA FOR ANIMALS FOR OUR TUBES

  Patient problems: Insufficient Information

  MAUDE report 11187497 ↗
• MalfunctionNov 23, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THERE WAS POOR BARRIER SEPARATION OF SAMPLE AND HEMOLYSIS OCCURRED. THIS OCCURRED ON 9 OCCASIONS WITH ANIMAL SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE SERUM TUBE IS NOT SEPARATING PROPERLY. CUSTOMER REPORTED THAT THE RED BLOOD CELLS ARE NOT SEPARATING IN THE SERUM SEPARATOR TUBES. THEY ARE USING THE 3.5ML TUBES, BUT DIDN'T KNOW THE PRODUCT OR LOT NUMBER AT THE TIME OF THE CALL. SHE ALSO DIDN'T KNOW WHEN THE INCIDENT STARTED OR IF THEY HAVE ANY SAMPLES THEY CAN RETURN IF NEEDED. THEY ARE USING THE TUBES ON ANIMALS, NOT PATIENTS. THEY HAVE USED SST TUBES IN THE PAST, AND HAVE NOT HAD AN ISSUE WITH THEM. THEY ARE USING 367981, LOT# 0122307. THEY ARE SEEING HEMOLYSIS IN 9 OF 10 BLOODS AND SO NOT FEEL THE HEMOLYSIS IS CAUSED BY A COLLECTION ISSUE. THE GEL MOVES BUT IS SMEARED UP THE SIDE OF THE TUBE. THE GEL LOOKS INTACT BEFORE DRAWING. THEY ALLOW THE BLOOD TO CLOT FULLY BEFORE CENTRIFUGATION, AND THEY SPIN FOR 15 MINUTES IN A SWING BUCKET CENTRIFUGE. SHE STATES THAT THEY HAVE CHANGED NOTHING IN THEIR PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10886925 ↗
• MalfunctionNov 23, 2020Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES EXPERIENCED UNDER-FILL, OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER EXPERIENCED UNDER FILLING WHEN USING VACUTAINERS. THE CUSTOMER COMPLAINED OF HAVING LOW VACUUM ISSUE WITH BD VACUTAINER SST TUBE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10886815 ↗
• MalfunctionJun 10, 2020Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT UNDER FILLING IS OCCURRING DURING USE WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WORK FOR A MEDICAL DEVICE COMPANY, AND WHILE COLLECTING VENIPUNCTURE BLOOD FOR A RESEARCH STUDY, WE HAVE HAD MULTIPLE PROBLEMS WITH ONE LOT OF BD SST-VACUTAINERS. THE LOT IS NOT SET TO EXPIRE UNTIL 30SEP2020, AND THE LOT NUMBER IS 9255587. WHILE OUR PHLEBOTOMIST WAS ATTEMPTING TO DRAW BLOOD, SHE WOULD PIERCE THE TOP OF THE VACUTAINERS AND NO VACUUM WOULD BE GENERATED, CAUSING HER TO HAVE TO USE MULTIPLE TUBES FOR ONE 3.5ML BLOOD DRAW. THIS CREATED A DISCOMFORT FOR OUR SUBJECTS, WHO ALREADY MAY HAVE HAD ANXIETY ABOUT THE BLOOD DRAW, AND MADE OUR PHLEBOTOMIST LOOK INEXPERIENCED, LEADING TO HER FEELING DISCOURAGED. WE LIKE TO USE BD VACUTAINERS FOR THESE COLLECTIONS, BUT THIS SET OF VACUTAINERS HAS BEEN COMPLETELY UNRELIABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10139042 ↗
• MalfunctionNov 21, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES EXPERIENCED ERRONEOUS RESULTS WHICH WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367981 BATCH NO. 9064643, 9123804, 9123802. COMPLAINT 1 OF 3. STARTED SEEING INCREASE IN AUGUST AND HAS BEEN INCREASING IN FREQUENCY. NO VISIBLE HEMOLYSIS. CUSTOMER IS WELL VERSED IN TROUBLESHOOTING AND HAS ADDITIONAL DATA IF NEEDED. PROBLEM K+'S ARE NOT LIMITED TO ONE SITE OR PHLEBOTOMIST, NURSE. TUBES ARE DRAW IN VARIOUS MANNER-STRAIGHT, LINES ETC. THEY MIX 5 TIMES, CLOT AT LEAST 30 MINUTES, NO RESPINNING, SPINNING ACCORDING TO RECOMMENDATIONS, USE CORRECT ORDER OF DRAW. THEIR REFERENCE RANGE IS 3.6-5.2 AND THEY ARE RUNNING UP TO 6.4 CURRENTLY. THEY RUN ON A BECKMAN DXCI 600. THEY DO NOT DRAW OR RUN PLASMA SAMPLES. THERE IS NO VISIBLE HEMOLYSIS. THEY HAVE DECANTED AND SENT THE SERUM TO (B)(4) AND THEY GET THE SAME RESULTS. SHE HAD HER PHLEBOTOMY SUPERVISOR DRAW PATIENTS USING 4 SST TUBES LABELLED 1,2,3,AND 4. THE RESULTS WERE AS FOLLOWS FOR TUBES,1,2,3 AND 4. 5.0, 5.0, 5.5, 5.0 SECOND PATIENT 5.4, 6.1, 5.3, 5.4. SHE ALSO HAD A PATIENT THAT HAD BEEN RUNNING AT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9355322 ↗
• MalfunctionSep 30, 2019Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE HAD FOREIGN "SPECKLES" IN IT, AND UNDERFILLED DURING USE DUE TO HAVING AN INADEQUATE VACUUM. THE "SPECKLES" WERE LATER CONFIRMED TO BE THE CLOT ACTIVATOR ADDITIVE SPRAY COATED ONTO THE TUBE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 6 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT HAS BEEN BROUGHT TO OUR ATTENTION BY A CUSTOMER COMPLAINT, REGARDING BD VACUTAINERS WITH SERUM SEPARATOR. THE VIALS HAVE SPECKLES ON THE INSIDE OF THE VIAL AND DID NOT HAVE ENOUGH SUCTION TO GET THE ADEQUATE AMOUNT OF BLOOD INTO THE VIAL. THESE VACUTAINERS HAVE BEEN EXPOSED TO TEMPERATURE LEVELS THAT EXCEED THE MANUFACTURES CONTROLLED TEMPERATURE COMPLIANCE THAT IS LISTED ON THE OUTSIDE OF THE VIAL." ADDITIONAL INFORMATION STATES: EXPLAINED THAT THE "SPECKLES" IN THESE TUBES ARE THE CLOT ACTIVATOR. IN THE EDTA TUBE, THE ADDITIVE IS SPRAY COATED ON THE SIDES AND THE CLOT ACTIVATOR IN SERUM TUBE IS ALSO SPRAY COATED ON THE SIDES OF THE WALLS. ALL OF THESE "SPECKLES" ARE NORMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9134656 ↗
• MalfunctionAug 23, 2019Short Fill; Short Fill

  MATERIAL NO. 367981, BATCH NO. 9123804. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES THE TUBE EXPERIENCED UNDER FILLING DURING TESTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING R&D TESTING IN (B)(4), WE OBSERVED TUBES WITH A DRAW VOLUME BELOW OUR MINIMUM SPECIFICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8926253 ↗
• MalfunctionAug 19, 2019Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT 2 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES EXPERIENCED UNDERFILL OR LOW DRAW DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367981 BATCH NO. 9064643. 367981 DOES NOT HAVE ANY VACUUM ISSUE FILLING TUBE DUE TO NO VACUUM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8905390 ↗
• MalfunctionJun 4, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS FOREIGN MATTER IN TUBES WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367981, BATCH NO. 9064643. IT WAS REPORTED THE CUSTOMER SEES SPECKLES IN THE TUBE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8668498 ↗
• MalfunctionSep 19, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BLACK FOREIGN MATTER WAS IN THE GEL OF THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7889195 ↗
• MalfunctionSep 13, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES THERE WAS AN ISSUE WITH FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7873932 ↗
• MalfunctionAug 13, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER SST BLOOD COLLECTION TUBES THERE WAS AN ISSUE WITH CRUSHED TUBES. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7778956 ↗
• MalfunctionJun 13, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES UNDERFILLED WHEN DRAWING BLOOD. NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO REPORT OF BLOOD EXPOSURE TO MUCOUS MEMBRANE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7597639 ↗
• MalfunctionJun 11, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HEMOLYSED. 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 7587063 ↗
• MalfunctionJun 7, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD POOR BARRIER SEPRATION CAUSED NO SERIOUS INJURY MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7578868 ↗
• MalfunctionJun 4, 2018Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD VACUUM COMPLAINT OF LOW DRAW. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR SERIOUS INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7567413 ↗
• MalfunctionMay 7, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD BUBBLES IN THE GEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7493013 ↗
• MalfunctionApr 19, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES CONTAINED FOREIGN MATTER.

  Patient problems: No Information

  MAUDE report 7443307 ↗
• MalfunctionDec 7, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT BD VACUTAINER® SST¿ TUBES HAD TWO TUBES WITH NO GEL. NO INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7096503 ↗

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-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.