BD Vacutainer® Plus Citrate Tube 363048Recalls & reported problems
Becton, Dickinson U.K. Limited · BD Vacutainer® Plus Citrate Tube · Class 2
All models of BD Vacutainer® Plus Citrate Tube (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Vacutainer Plus citrate tube is used to collect blood samples for testing. Its 457 reports mostly describe tubes filled too little or too much, with some describing inaccurate results and leaks or splashes. The reports include no deaths and 2 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 459
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 459 adverse event reports that list this exact device (DI 30382903630487), received between Nov 27, 2017 and Sep 21, 2026 — classified as 2 injuries, 457 malfunctions.
The most frequently reported specific device problem is “Short Fill” (189 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.
Reports received per month
Most reported problems
Device problems
- Short Fill189
- Overfill134
- Volume Accuracy Problem93
- Incorrect, Inadequate or Imprecise Result or Readings35
- Leak/Splash28
- Coagulation in Device or Device Ingredient19
- Device Contamination with Chemical or Other Material12
- Device Ingredient or Reagent Problem9
Patient problems
- No Known Impact Or Consequence To Patient239
- No Clinical Signs, Symptoms or Conditions145
- No Consequences Or Impact To Patient46
- No Information24
- No Patient Involvement6
- No Code Available2
- Pain2
Recent adverse event reports
The 25 most recent of 459 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Incorrect, Inadequate or Imprecise Result or Readings; Overfill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841673 ↗MalfunctionSep 21, 2026Incorrect, Inadequate or Imprecise Result or Readings; Overfill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841667 ↗MalfunctionMar 19, 2026Overfill
IT WAS REPORTED WHILE USING BD VACUTAINER® PLUS CITRATE TUBE, AN UNSPECIFIED NUMBER OF TUBES FILL BEYOND THE FILL LINE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24639588 ↗MalfunctionMar 16, 2026Overfill
IT WAS REPORTED WHILE USING BD VACUTAINER® PLUS CITRATE TUBE, AN UNSPECIFIED NUMBER OF TUBES FILL ABOVE THE FILL LINE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24612394 ↗MalfunctionFeb 11, 2026Overfill
IT WAS REPORTED WHILE USING BD VACUTAINER® PLUS CITRATE TUBE, 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 24314357 ↗MalfunctionFeb 4, 2026Overfill
IT WAS REPORTED WHILE USING BD VACUTAINER® PLUS CITRATE TUBE, AN UNSPECIFIED NUMBER OF TUBES OVERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24261900 ↗MalfunctionJan 13, 2026Overfill
IT WAS REPORTED WHILE USING BD VACUTAINER® PLUS CITRATE TUBE, AN UNSPECIFIED NUMBER OF TUBES OVERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24059208 ↗MalfunctionJan 7, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® PLUS CITRATE TUBE, AN UNSPECIFIED NUMBER OF TUBES FLAG AS UNDERFILLED ON CUSTOMER'S INSTRUMENT. THEY REPORTED GREINER CITRATE TUBES AND BD CITRATE TUBES ARE PROCESSED ON THIS INSTRUMENT. THEY OBSERVE SIGNIFICANTLY MORE UNDERFILLING FLAGS ON THE BD TUBES. TUBES WERE NOT CHECKED VISUALLY. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23991749 ↗MalfunctionDec 16, 2025Overfill; Overfill
IT WAS REPORTED WHILE USING BD VACUTAINER® PLUS CITRATE TUBE, 26 TUBES WERE OVERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23821282 ↗MalfunctionDec 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 3 OF 3: IT WAS REPORTED WHILE USING BD VACUTAINER® PLUS CITRATE TUBE, AN UNSPECIFIED NUMBER OF TUBES EXHIBITED UNSPECIFIED ERRONEOUS RESULTS. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23708178 ↗MalfunctionDec 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 2 OF 3: IT WAS REPORTED WHILE USING BD VACUTAINER® PLUS CITRATE TUBE, AN UNSPECIFIED NUMBER OF TUBES EXHIBITED UNSPECIFIED ERRONEOUS RESULTS. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23708177 ↗MalfunctionDec 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 1 OF 3: IT WAS REPORTED WHILE USING BD VACUTAINER® PLUS CITRATE TUBE, 1 PATIENT SAMPLE EXHIBITED ERRONEOUS HIGH D-DIMER RESULTS. THE PATIENT WAS SENT TO THE EMERGENCY ROOM AND A NEW SAMPLE WAS COLLECTED WHICH WAS LOWER. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23708148 ↗MalfunctionDec 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD VACUTAINER® PLUS CITRATE TUBE, 1 PATIENT SAMPLE EXHIBITED ERRONEOUS HIGH D-DIMER RESULTS. THE PATIENT WAS SENT TO THE EMERGENCY ROOM AND A NEW SAMPLE WAS COLLECTED WHICH WAS LOWER. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23708145 ↗MalfunctionNov 7, 2025Short Fill; Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® PLUS CITRATE TUBE, 15 TUBES UNDERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23496880 ↗MalfunctionOct 16, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT BEFORE USING THE BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES, A TOTAL OF FIVE (5) TUBES HAD NO LABELS ON THEM. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23310947 ↗MalfunctionSep 3, 2025Overfill; Overfill
REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® PLUS CITRATE TUBE AN UNSPECIFIED NUMBER OF SAMPLES OVERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22955734 ↗MalfunctionSep 3, 2025Overfill; Overfill
REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® PLUS CITRATE TUBE AN UNSPECIFIED NUMBER OF SAMPLES OVERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22954505 ↗MalfunctionJul 29, 2025Overfill; Overfill
IT WAS REPORTED WHILE USING BD VACUTAINER® PLUS CITRATE TUBE, 10 SAMPLES WERE OVERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22644501 ↗MalfunctionJul 15, 2025Overfill; Overfill
IT WAS REPORTED WHILE USING BD VACUTAINER® PLUS CITRATE TUBE, AN UNSPECIFIED NUMBER OF SAMPLES ARE OVERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22510287 ↗MalfunctionJun 23, 2025Short Fill; Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® PLUS CITRATE TUBE, 1 TUBES WAS UNDERFILLED. A REPLACEMENT TUBE WAS USED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22307610 ↗MalfunctionJun 17, 2025Overfill; Overfill
IT WAS REPORTED DURING USE OF BD VACUTAINER® PLUS CITRATE TUBE, AN UNSPECIFIED NUMBER OF SAMPLES ARE OVERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22234112 ↗MalfunctionJun 16, 2025Overfill; Overfill
IT WAS REPORTED DURING USE OF BD VACUTAINER® PLUS CITRATE TUBE, AN UNSPECIFIED NUMBER OF SAMPLES ARE OVERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22214509 ↗MalfunctionJun 16, 2025Overfill; Overfill
IT WAS REPORTED DURING USE OF BD VACUTAINER® PLUS CITRATE TUBE, AN UNSPECIFIED NUMBER OF SAMPLES ARE OVERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22214107 ↗MalfunctionMay 28, 2025Overfill; Overfill
IT WAS REPORTED WHILE USING BD VACUTAINER® PLUS CITRATE TUBE, 5 TUBES WERE OVERFILLED AND REJECTED BY THEIR AUTOMATED INSTRUMENT. SAMPLES WERE RECOLLECTED. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22101099 ↗MalfunctionMay 13, 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 SAMPLES AT DIFFERENT COLLECTION LEVELS(BUT STILL BETWEEN MINIMUM AND MAXIMUM COLLECTION VOLUME) PRODUCED 2 DIFFERENT APTT RESULTS - 26.9 VERSUS 28.1. RESULTS WERE REPORTED TO CLINICIAN. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22014025 ↗
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-2258-2018 · Apr 11, 2018 · TerminatedThe 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-2259-2018 · Apr 11, 2018 · TerminatedThe 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 · TerminatedThe 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 · TerminatedBD 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 · TerminatedBD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL
Other Tubes, vials, systems, serum separators, blood collection devices
- BD Vacutainer® SST™ 367986Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection2 recalls2,711 reports
- BD Vacutainer® Buffered Sodium Citrate (9NC) Blood Collection Tubes 363083Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1 recall1,744 reports
- BD Vacutainer® SST™ II Advance 367955Becton, Dickinson U.K. Limited · Tubes, vials, systems, serum separators, blood collection1,478 reports
- BD Vacutainer® Eclipse™ Blood Collection Needle 368607Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1,220 reports
- BD Vacutainer® SST™ 367983Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection2 recalls1,075 reports
- BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes 367856Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1,010 reports
- BD Vacutainer® PST™ Gel and Lithium HeparinN 56 Units 367960Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1 recall747 reports
- BD Vacutainer® SST™ II Advance 367957Becton, Dickinson U.K. Limited · Tubes, vials, systems, serum separators, blood collection767 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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