BD Vacutainer® Sodium Fluoride/Potassium Oxalate 5mg/4mg 367921Recalls & reported problems
Becton, Dickinson And Company · BD Vacutainer® Sodium Fluoride Potassium Oxalate 5mg/4mg · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Vacutainer sodium fluoride blood collection tube has 194 reports and no injuries or deaths. Many reports describe tubes that were underfilled, and some describe clotting inside the tube or inaccurate results. Reports fell from 34 in the prior 12 months to 10 in the most recent 12 months. 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
- 197
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 197 adverse event reports that list this exact device (DI 30382903679219), received between Dec 5, 2017 and Sep 28, 2026 — classified as 197 malfunctions.
The most frequently reported specific device problem is “Short Fill” (65 reports).
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 Fill65
- Incorrect, Inadequate or Imprecise Result or Readings34
- Coagulation in Device or Device Ingredient22
- Volume Accuracy Problem20
- Device Contamination with Chemical or Other Material16
- Device Ingredient or Reagent Problem16
- Incorrect Or Inadequate Test Results10
- Leak/Splash9
Patient problems
- No Clinical Signs, Symptoms or Conditions138
- No Known Impact Or Consequence To Patient40
- No Consequences Or Impact To Patient11
- No Information6
- No Patient Involvement3
Recent adverse event reports
The 25 most recent of 197 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Short Fill
Report 2 of 3.It was reported that when using the BD Vacutainer® Sodium Fluoride 5mg Potassium Oxalate 4 mg (FX) Blood Collection Tubes, 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 50916241 ↗MalfunctionSep 28, 2026Short Fill
Report 1 of 3.It was reported that when using the BD Vacutainer® Sodium Fluoride 5mg Potassium Oxalate 4 mg (FX) Blood Collection Tubes, 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 50916238 ↗MalfunctionSep 28, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916237 ↗MalfunctionMay 11, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG, 5 TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25144514 ↗MalfunctionApr 20, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG, 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 24934034 ↗MalfunctionApr 1, 2026Short Fill
REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG, 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 24757181 ↗MalfunctionApr 1, 2026Short Fill
REPORT 2 OF 2. IT WAS REPORTED WHILE USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG, 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 24757179 ↗MalfunctionJan 27, 2026Short Fill
IT WAS REPORTED WHILE USING AN UNSPECIFIED BD VACUTAINER® GRAY TOP TUBE, 2 TUBES WERE UNDERFILLED ON THE SAME PATIENT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24193754 ↗MalfunctionJan 6, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG, 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 23985043 ↗MalfunctionJan 6, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG, 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 23985019 ↗MalfunctionJan 6, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG, 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 23976433 ↗MalfunctionNov 26, 2025Short Fill; Short Fill
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG, ONE (1) TUBE UNDERFILLED. A REPLACEMENT TUBING WAS USED TO COMPLETE THE DRAW. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23662630 ↗MalfunctionNov 11, 2025Short Fill; Improper Chemical Reaction; Short Fill; Improper Chemical Reaction
IT WAS REPORTED WHILE USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED AND EXHIBITED HEMOLYSIS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23526410 ↗MalfunctionOct 21, 2025Backflow; Short Fill; Backflow; Short Fill
IT WAS REPORTED DURING BLOOD COLLECTION USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG, 1 TUBE WAS UNDERFILLED AND BLOOD FLOW STOPPED. SAMPLE BACK-FLOWED IN ACQUISITION DEVICE BACK TO PATIENT. THE TUBE WAS REPLACED. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23350414 ↗MalfunctionSep 5, 2025Excessive Heating; Excessive Heating
IT WAS REPORTED WHILE USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG, AN UNSPECIFIED NUMBER OF TUBES WERE STORED AT INCORRECT TEMPERATURE PRIOR TO USE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977607 ↗MalfunctionSep 3, 2025Short Fill; Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG, 1 TUBE UNDERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22959886 ↗MalfunctionSep 3, 2025Short Fill; Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG, 2 TUBES WERE UNDERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22958408 ↗MalfunctionAug 19, 2025Short Fill; Short Fill
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG, THE CUSTOMER NOTICED VACUUM IS EXHAUSTED AND BLOOD FLOW CEASES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22841912 ↗MalfunctionAug 18, 2025Short Fill; Short Fill
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG, THE TUBES ARE UNDERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22834181 ↗MalfunctionAug 18, 2025Short Fill; Improper Chemical Reaction; Short Fill; Improper Chemical Reaction
IT WAS REPORTED WHILE USING THE BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES THERE WAS LOW SAMPLE DRAW VOLUME COLLECTED AND SAMPLE HEMOLYSIS IN AN UNSPECIFIED NUMBER OF DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22827633 ↗MalfunctionAug 15, 2025Short Fill; Short Fill
IT WAS REPORTED THAT WHILE USING ONE BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG, THE CUSTOMER NOTICED THAT THE TUBE UNDERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22818775 ↗MalfunctionJul 29, 2025Short Fill; Improper Chemical Reaction; Short Fill; Improper Chemical Reaction
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG THERE WAS LOW SAMPLE DRAW VOLUME AND SAMPLE HEMOLYSIS IN AN UNSPECIFIED NUMBER OF DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22644482 ↗MalfunctionJul 28, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG ONE TUBE WAS CRACKED AND SPECIMEN LEAKED ON ONE DEVICE. THERE WAS ALSO LOW SAMPLE DRAW VOLUME ON THE SAME DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22634492 ↗MalfunctionJul 23, 2025Short Fill; Short Fill
IT WAS REPORTED THAT WHILE USING ONE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE, THE TUBE UNDERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22576953 ↗MalfunctionJul 23, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BEFORE USING ONE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE, THE CUSTOMER NOTICED THE CAP STOPPER WAS DEFORMED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22575980 ↗
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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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