BD Vacutainer® Serum 367814Recalls & reported problems
Becton, Dickinson And Company · BD Vacutainer® Serum · Class 2
All models of BD Vacutainer Serum (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BD Vacutainer Serum blood collection tube is used to collect blood samples. Of the 161 reports, many describe tubes that are underfilled or have weak vacuum, and some describe cracked tubes or blood leaking from the cap. The reports include no deaths or injuries, and reports fell to 19 in the last 12 months from 33 before. 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
- 164
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 164 adverse event reports that list this exact device (DI 30382903678144), received between Apr 2, 2018 and Sep 30, 2026 — classified as 164 malfunctions.
The most frequently reported specific device problem is “Short Fill” (71 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Short Fill71
- Coagulation in Device or Device Ingredient15
- Incorrect, Inadequate or Imprecise Result or Readings15
- Volume Accuracy Problem15
- Difficult to Insert14
- Leak/Splash14
- Device Contamination with Chemical or Other Material12
- Device Markings/Labelling Problem8
Patient problems
- No Clinical Signs, Symptoms or Conditions118
- No Known Impact Or Consequence To Patient36
- No Consequences Or Impact To Patient9
- Hemolysis2
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 164 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Short Fill
It was reported that when using the BD Vacutainer® Serum Blood Collection Tubes, one (1) tube exhibited backflow, requiring recollection. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946959 ↗MalfunctionSep 29, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941169 ↗MalfunctionSep 29, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941160 ↗MalfunctionMay 27, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, ONE (1) TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25309538 ↗MalfunctionMay 18, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES HAD INSUFFICIENT NEGATIVE PRESSURE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25209289 ↗MalfunctionMay 18, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, TWO TUBES EXHIBITED INSUFFICIENT NEGATIVE PRESSURE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25201914 ↗MalfunctionMay 5, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, ONE (1) TUBE UNDERFILLED DUE TO TUBE PUSH OFF. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25089040 ↗MalfunctionApr 23, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, ONE TUBE WAS CRACKED RESULTING IN SAMPLE LEAKAGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24971286 ↗MalfunctionApr 22, 2026Fluid/Blood Leak
IT WAS REPORTED AFTER USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, ONE (1) TUBE LEAKED BLOOD FROM THE HEMOGARD CAP. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24957008 ↗MalfunctionApr 21, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, TWO (2) TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24947993 ↗MalfunctionJan 26, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, 1 TUBE WAS UNDERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24179885 ↗MalfunctionJan 14, 2026Leak/Splash
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, THE CAP OF TWO TUBES CAME OFF RESULTING IN SAMPLE LEAKAGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24075278 ↗MalfunctionJan 12, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, 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 24048621 ↗MalfunctionJan 7, 2026Difficult to Insert
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, TUBE PUSH OFF OCCURRED WITH 20 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23995951 ↗MalfunctionJan 2, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, THE STOPPER POPPED OFF OF FIVE TUBES RESULTING IN SAMPLE LEAKAGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23944242 ↗MalfunctionJan 2, 2026Product Quality Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, THE RUBBER STOPPER OF ONE TUBE WAS INVERTED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23944237 ↗MalfunctionDec 19, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SERUM, THE NON-PATIENT CANNULA DISENGAGES UPON ATTACHMENT TO THE TUBE, 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 23849017 ↗MalfunctionDec 4, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, THE CAP OF ONE TUBE DETACHED RESULTING IN SAMPLE LEAKAGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23723069 ↗MalfunctionDec 2, 2025Material Deformation; Material Deformation
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, THE RUBBER STOPPER OF ONE TUBE IS DEFECTIVE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23692253 ↗MalfunctionDec 1, 2025Short Fill; Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, ONE TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23688416 ↗MalfunctionDec 1, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, ONE TUBE DID NOT HAVE A SCALE MARK, RESULTING IN THE INABILITY TO IDENTIFY THE BLOOD COLLECTION DOSE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23688040 ↗MalfunctionNov 19, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, TUBE PUSH OFF WAS SEEN WITH AN UNSPECIFIED NUMBER OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23597911 ↗MalfunctionOct 22, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, WHITE ADDITIVE WAS SEEN INSIDE OF ONE TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23358867 ↗MalfunctionOct 15, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, THE NEEDLE EJECTED FROM THE TUBE. THIS OCCURRED WITH ONE DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23305848 ↗MalfunctionSep 18, 2025Fluid/Blood Leak; Short Fill; Fluid/Blood Leak; Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, THREE TUBES UNDERFILLED AND AN UNSPECIFIED NUMBER OF TUBES EXHIBITED SAMPLE LEAKAGE ONTO THE CUSTOMER'S HAND AND FLOOR. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23090529 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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