BD Vacutainer® Plus Citrate Tube 363047Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 30382903630470), received between May 1, 2018 and Sep 10, 2026 — classified as 75 malfunctions.

The most frequently reported specific device problem is “Short Fill” (34 reports).

5 other recalls cover devices cleared under the same FDA submission (K013971); 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 75 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported while using BD Vacutainer® 9NC 0.109M Buffered Trisodium Citrate Plus Blood Collection Tubes, an unspecified number of tubes produced unspecified erroneous results. Samples were retested. There was no health impact or consequences reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722233 ↗
• MalfunctionMar 25, 2026Short Fill

  REPORT 2 OF 2 IT WAS REPORTED WHILE USING BD VACUTAINER® PLUS CITRATE TUBE, 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 24688591 ↗
• MalfunctionMar 25, 2026Short Fill

  REPORT 1 OF 2. IT WAS REPORTED WHILE USING BD VACUTAINER® PLUS CITRATE TUBE, ONE TUBE UNDERFILLED RESULTING IN SAMPLE RECOLLECTION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688494 ↗
• MalfunctionFeb 27, 2026Overfill

  IT WAS REPORTED WHILE USING BD VACUTAINER® PLUS CITRATE TUBES, AN UNSPECIFIED NUMBER OF TUBES OVERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472047 ↗
• MalfunctionDec 19, 2025Overfill; Overfill

  IT WAS REPORTED WHILE USING BD VACUTAINER® PLUS CITRATE TUBE, AN UNSPECIFIED NUMBER OF TUBES APPEAR TO BE OVERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23855033 ↗
• MalfunctionDec 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD VACUTAINER® PLUS CITRATE TUBE, 2 ERRONEOUS INR RESULTS (FALSELY LOW) WERE OBTAINED ON THE SAME PATIENT AND SAMPLE. THE PATIENT RECEIVED THE INITIAL LOW RESULTS AND WAS ADVISED TO INCREASE THEIR MEDICATION DOSE. PRIOR TO MEDICATION CHANGE, THE PATIENT WAS RETESTED THE SAME DAY AT A DIFFERENT LOCATION WITH A NEW SAMPLE AND THE RESULT WAS WITHIN THERAPEUTIC LIMITS. THE INITIAL SAMPLE WAS RE-TESTED AND THE ERRONEOUS LOW INR WAS REPLICATED ON THE SAME SAMPLE. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23774478 ↗
• MalfunctionJul 29, 2025Short Fill; Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® PLUS CITRATE TUBE, AN UNSPECIFIED NUMBER OF TUBES WERE UNDERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22644483 ↗
• MalfunctionApr 24, 2025Overfill; Overfill

  IT WAS REPORTED WHILE USING BD VACUTAINER® PLUS CITRATE TUBE, 2 TUBES WERE OVERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900540 ↗
• MalfunctionFeb 24, 2025Overfill; Overfill

  IT WAS REPORTED WHILE USING BD VACUTAINER® PLUS CITRATE TUBE, AN UNSPECIFIED NUMBER OF TUBES OVERFILLED RESULTING IN SAMPLE RECOLLECTION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446622 ↗
• MalfunctionJan 16, 2025Short Fill; Short Fill

  IT WAS REPORTED DURING USE OF BD VACUTAINER® PLUS CITRATE TUBE, AN UNSPECIFIED NUMBER OF TUBES ARE UNDERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21168578 ↗
• MalfunctionJan 7, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PATIENT 2 OF 2: IT WAS REPORTED DURING USE OF BD VACUTAINER® PLUS CITRATE TUBE, ERRONEOUS PT AND PTT RESULTS OCCURRED IN ONE PATIENT SAMPLE. TESTING OF A NEW SAMPLE WERE NORMAL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21091053 ↗
• MalfunctionJan 7, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PATIENT 1 OF 2: IT WAS REPORTED DURING USE OF BD VACUTAINER® PLUS CITRATE TUBE, ERRONEOUS PT AND PTT RESULTS OCCURRED IN ONE PATIENT SAMPLE. TESTING OF A NEW SAMPLE WERE NORMAL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21090969 ↗
• MalfunctionOct 3, 2024Short Fill; Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® PLUS CITRATE TUBE, AN UNSPECIFIED NUMBER OF TUBES ARE UNDERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20362231 ↗
• MalfunctionJul 19, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES 1 TUBE HAD A DIFFERENT CAP COLOR. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19781639 ↗
• MalfunctionJul 7, 2023Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES HAD VOLUME ERROR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "FOR THE PAST 1 WEEK, PEDIATRIC CITRATE TUBES IN THE ICU HAVE BEEN IN VOLUME ERROR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17280110 ↗
• MalfunctionDec 7, 2022Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE 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: "FOR SEVERAL MONTHS NOW, THE SAMPLING DEPARTMENTS HAVE BEEN REPORTING DIFFICULTIES IN FILLING THESE TUBES. THESE FILLING PROBLEMS STARTED AT THE BEGINNING OF THE SUMMER (JUNE-JULY). WE HAVE NOT IDENTIFIED ANY PARTICULAR BATCH OF TUBES (SEVERAL BATCHES CONCERNED), HOWEVER, IN THE TECHNICAL DATA SHEET IT IS SPECIFIED THAT THE TUBES MUST BE STORED BETWEEN 4 AND 25°C.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15934760 ↗
• MalfunctionDec 7, 2022Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® BLOOD COLLECTION TUBE BUFFERED SODIUM CITRATE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "FOR SEVERAL MONTHS NOW, THE SAMPLING DEPARTMENTS HAVE BEEN REPORTING DIFFICULTIES IN FILLING THESE TUBES. THESE FILLING PROBLEMS STARTED AT THE BEGINNING OF THE SUMMER (JUNE-JULY). WE HAVE NOT IDENTIFIED ANY PARTICULAR BATCH OF TUBES (SEVERAL BATCHES CONCERNED), HOWEVER, IN THE TECHNICAL DATA SHEET IT IS SPECIFIED THAT THE TUBES MUST BE STORED BETWEEN 4 AND 25°C."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15934402 ↗
• MalfunctionMay 7, 2022Clumping in Device or Device Ingredient; Incorrect, Inadequate or Imprecise Result or Readings; Clumping in Device or Device Ingredient; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED CLOGGED / BLOCKED INSTRUMENT PROBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: A TP/TCK/FIB/DD WAS REQUESTED BY THE EMERGENCY DEPARTMENT. OUR STA-R MAX II AUTOMATED SYSTEM RETURNED ALL PARAMETERS WITHOUT ALARM ON THE BLOCKED PRIMARY TUBE. ALL RESULTS WERE NORMAL ALL RESULTS WERE NORMAL EXCEPT THE PT WHICH WAS VERY LOW (28%) FOR A PATIENT NOT TAKING ANY ANTICOAGULANT TREATMENT. THE LOWERED PT RESULT WAS CHECKED AND THE MACHINE RETURNED THE SAME VALUE (31%) FOR THE SECOND ASSAY, AGAIN FROM THE BLOCKED PRIMARY TUBE. PRIMARY TUBE. AFTER DISCUSSION WITH THE EMERGENCY PHYSICIAN, WE DECIDED TO ADD A COMPLETE LIVER WORK-UP, AN ALCOHOL LEVEL AND THE DETERMINATION OF FACTORS II, V, VII AND VIII. FACTORS II, V, VII AND X. THE DOCTOR WANTED THE FULL WORK-UP IN ORDER TO BE ABLE TO HOSPITALISE HIS PATIENT IN A CONTEXT OF SHORTAGE OF HOSPITAL PLACES. BEFOREHAND, WE TOOK THE PRIMARY TUBE OUT OF THE MACHINE AND ALIQUOTED IT. THE FACTORS WERE THEREFORE MEASURED ON AN ALIQUOT: ALL THE FACTORS CAME BACK NORMAL. WE LOOKED FOR T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14322184 ↗
• MalfunctionApr 12, 2022Blocked Connection; Blocked Connection

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBE THERE WAS CLOGGED/BLOCKED INSTRUMENTATION PROBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE LABORATORY USES THESE TUBES ON TWO STAGO STARMAX MACHINES. THERE ARE PROBLEMS WITH THESE MACHINES, PIECES OF PLUGS ARE BLOCKING THE NEEDLES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14090391 ↗
• MalfunctionMar 29, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED A STERILITY ISSUES . THIS EVENT OCCURRED THREE TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: A PART OF THE CAP IS MISSING FOR 3 TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13943959 ↗
• MalfunctionMar 21, 2022Coagulation in Device or Device Ingredient; Incorrect, Inadequate or Imprecise Result or Readings; Coagulation in Device or Device Ingredient; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE BD VACUTAINER® 9NC BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBE HAD PROLONGED PTT ACTIVATION AND CLOTTED DURING A COAGULATION STUDY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON A NIGHT SHIFT EARLIER THIS WEEK, COAGULATION STUDIES WERE COLLECTED IN BD VACUTAINER 9NC 0.109M BUFF, NA3, CITRATE, REF (B)(4) LOT 1242115, 1.8 ML MICROTAINER. RESULT THAT WAS RECIEVED BY THE UNIT WAS EXTREMELY PROLONGED. CLINICIAN NOTED THE EXPIRY DATE ON THE TUBES WAS 2022-02 (BELIEVE THIS MEANS IT SHOULDN¿T BE EXPIRED UNTIL THE END OF THE MONTH FEB 28). CLINICIAL REMOVED TUBES FROM THE LAB CART AND I UNDERSTAND THEY WERE DISCARDED. TODAY ANOTHER NURSE CLINICIAN/CHARGE NURSE REPORTED A SIMILAR EVENT ON A DIFFERENT PATIENT. I GUESS SOME OF THE TUBES WERE STILL ON EITHER THE LAB CART OR THE MEGA CART, I REALLY DON'T KNOW WHERE IT CAME FROM. AT ANY RATE, THE PTT WAS AGAIN VERY PROLONGED. THE UNIT CALLED THE LAB FOR TUBES AND WERE SENT BD VACUTAINER BUFF, NA, CITRATE, 0.109M 3.2% REF (B)(4) LOT 1319175 EXP 2022-05-31, 1.8 ML. THE CHARGE NURSE ACKNOWLEDGED THAT SOME CLINICAL CORRECTIONS HAD TAKEN PLACE (FFP AND VIT K I BELIEVE), AND THE COAG STUDIES IN T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13840353 ↗
• MalfunctionNov 4, 2021Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® 9NC BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED BLOOD CLOTTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WE RECENTLY RECEIVED A FEW CITRATE TUBES IN THE LAB THAT CONTAIN COMPLETELY CLOTTED BLOOD, WITH A 'GEL-LIKE' SUBSTANCE ON TOP. WE INQUIRED WITH THE PERSON WHO TOOK THE SAMPLE AND THERE HAD BEEN NO CALAMITIES DURING THE COLLECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12751622 ↗
• MalfunctionOct 22, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT WAS REPORTED TO OCCUR 2000 TIMES. THE CUSTOMER STATES THEY HAD TO "DESTROY 2500 UNUSED TUBES." THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER AND TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "THE REAGENT IN THE TUBE NO LONGER WORKS." ADDITIONAL INFORMATION RECEIVED: THE CUSTOMER STATED: "OUR LABORATORY INFORMED US THAT THEY HAD RECEIVED TUBES THAT WERE NOT FILLED CORRECTLY, WE TRIED SEVERAL TIMES WITH TUBES FROM THE SAME BATCH AND FOUND THE SAME ANOMALY, THE TUBES COULD NOT BE ANALYZED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12682417 ↗
• MalfunctionSep 15, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBE THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WAS "FOREIGN MATTER IN THE TUBE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12475777 ↗
• MalfunctionAug 27, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED CLOTTING / MICRO CLOTS/FIBRIN CLOTS. THIS EVENT OCCURRED TWO TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WE HAD 2X A PROBLEM WITH THE PEDIATRIC CITRATE TUBES LOT 1085027 DP: (B)(6) 2021. WE TOOK FROM 2 CHILDREN THE PLATELET AGGREGATION ON THEM AND THE LABORATORY ASSISTANTS CAME BACK TO US, SPECIFYING THAT THE BLOOD WAS COAGULATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12380239 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K013971. One submission often covers many models, so check the product and lot details in each record.

• Z-2259-2018 · Apr 11, 2018 · Terminated
  The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and processing blood in a clos
• Z-2258-2018 · Apr 11, 2018 · Terminated
  The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and processing blood in a clos
• Z-2260-2018 · Apr 11, 2018 · Terminated
  The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and processing blood in a clos
• Z-2633-2014 · Jun 23, 2014 · Terminated
  BD Vacutainer Citrate Tubes (LIGHT BLUE TOP TUBE 2.7ML)Part number: BD 363083 Part Number: FMC 87-3083-8 Single use tube used to collect, separate, transport or process blood spec
• Z-0756-2013 · Nov 12, 2012 · Terminated
  BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL