BD Vacutainer® Urine Analysis Preservative Tube 364992Recalls & reported problems
Becton, Dickinson And Company · TUBE URIN PLC 16X100 8.0 UAP CONI RD/YEL · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Vacutainer urine analysis preservative tube is a specimen collection tube for urine tests. Many reports describe tubes that are underfilled, and others describe rubber particles from the stopper that clogged an analyzer probe. The 159 reports include no deaths and no injuries. No recalls name this device, and reports rose from 11 in the prior 12 months to 36 in the latest 12 months.
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
- 160
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 160 adverse event reports that list this exact device (DI 30382903649922), received between Nov 7, 2017 and Sep 25, 2026 — classified as 160 malfunctions.
The most frequently reported specific device problem is “Short Fill” (68 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 Fill68
- Incorrect, Inadequate or Imprecise Result or Readings24
- Device Contamination with Chemical or Other Material16
- Leak/Splash15
- Device Markings/Labelling Problem13
- Incorrect Or Inadequate Test Results13
- Volume Accuracy Problem6
- Material Deformation5
Patient problems
- No Clinical Signs, Symptoms or Conditions93
- No Known Impact Or Consequence To Patient49
- No Consequences Or Impact To Patient13
- No Information4
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 160 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Device Contamination with Chemical or Other Material
It was reported while using BD Vacutainer® Urine Analysis Preservative Tube, the urine analyzer triggered the ¿check for crystals¿ alarm; however, upon reviewing the captured images, no crystals were visible, only black streaks. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900115 ↗MalfunctionJun 10, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT PRIOR TO USE OF A BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE, THE CUSTOMER OBSERVED RUBBER PARTICLES ORIGINATING FROM THE TUBE STOPPER INSIDE THE TUBE. DURING SAMPLE PROCESSING, THE ANALYZER PROBE ASPIRATED THE PARTICLES, RESULTING IN PROBE CLOGGING. NO ADVERSE PATIENT OR USER IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25453108 ↗MalfunctionMay 20, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE, AN UNSPECIFIED NUMBER OF TUBES ARE NOT FILLING TO THE MINIMUM FILL LINE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25233373 ↗MalfunctionMay 6, 2026Short Fill
REPORT 17 OF 19: IT WAS REPORTED WHILE USING BD VACUTAINER® URINE ANALYSIS PRESERVATIVE 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 25106895 ↗MalfunctionMay 6, 2026Short Fill
REPORT 19 OF 19: IT WAS REPORTED WHILE USING BD VACUTAINER® URINE ANALYSIS PRESERVATIVE 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 25104822 ↗MalfunctionMay 6, 2026Short Fill
REPORT 15 OF 19: IT WAS REPORTED WHILE USING BD VACUTAINER® URINE ANALYSIS PRESERVATIVE 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 25104816 ↗MalfunctionMay 6, 2026Short Fill
REPORT 16 OF 19: IT WAS REPORTED WHILE USING BD VACUTAINER® URINE ANALYSIS PRESERVATIVE 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 25104812 ↗MalfunctionMay 6, 2026Short Fill
REPORT 12 OF 19: IT WAS REPORTED WHILE USING BD VACUTAINER® URINE ANALYSIS PRESERVATIVE 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 25104811 ↗MalfunctionMay 6, 2026Short Fill
REPORT 13 OF 19: IT WAS REPORTED WHILE USING BD VACUTAINER® URINE ANALYSIS PRESERVATIVE 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 25104810 ↗MalfunctionMay 6, 2026Short Fill
REPORT 14 OF 19: IT WAS REPORTED WHILE USING BD VACUTAINER® URINE ANALYSIS PRESERVATIVE 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 25104809 ↗MalfunctionMay 6, 2026Short Fill
REPORT 11 OF 19: IT WAS REPORTED WHILE USING BD VACUTAINER® URINE ANALYSIS PRESERVATIVE 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 25104808 ↗MalfunctionMay 6, 2026Short Fill
REPORT 18 OF 19: IT WAS REPORTED WHILE USING BD VACUTAINER® URINE ANALYSIS PRESERVATIVE 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 25104807 ↗MalfunctionMay 6, 2026Short Fill
REPORT 1 OF 19: IT WAS REPORTED WHILE USING BD VACUTAINER® URINE ANALYSIS PRESERVATIVE 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 25104496 ↗MalfunctionMay 6, 2026Short Fill
REPORT 8 OF 19: IT WAS REPORTED WHILE USING BD VACUTAINER® URINE ANALYSIS PRESERVATIVE 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 25104429 ↗MalfunctionMay 6, 2026Short Fill
REPORT 7 OF 19: IT WAS REPORTED WHILE USING BD VACUTAINER® URINE ANALYSIS PRESERVATIVE 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 25104426 ↗MalfunctionMay 6, 2026Short Fill
REPORT 10 OF 19: IT WAS REPORTED WHILE USING BD VACUTAINER® URINE ANALYSIS PRESERVATIVE 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 25104409 ↗MalfunctionMay 6, 2026Short Fill
REPORT 2 OF 19: IT WAS REPORTED WHILE USING BD VACUTAINER® URINE ANALYSIS PRESERVATIVE 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 25104402 ↗MalfunctionMay 6, 2026Short Fill
REPORT 5 OF 19: IT WAS REPORTED WHILE USING BD VACUTAINER® URINE ANALYSIS PRESERVATIVE 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 25104392 ↗MalfunctionMay 6, 2026Short Fill
REPORT 4 OF 19: IT WAS REPORTED WHILE USING BD VACUTAINER® URINE ANALYSIS PRESERVATIVE 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 25104350 ↗MalfunctionMay 6, 2026Short Fill
REPORT 6 OF 19: IT WAS REPORTED WHILE USING BD VACUTAINER® URINE ANALYSIS PRESERVATIVE 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 25104345 ↗MalfunctionMay 6, 2026Short Fill
REPORT 3 OF 19: IT WAS REPORTED WHILE USING BD VACUTAINER® URINE ANALYSIS PRESERVATIVE 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 25104282 ↗MalfunctionMay 6, 2026Short Fill
REPORT 9 OF 19. IT WAS REPORTED WHILE USING BD VACUTAINER® URINE ANALYSIS PRESERVATIVE 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 25104176 ↗MalfunctionApr 15, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® URINE ANALYSIS PRESERVATIVE 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 24883844 ↗MalfunctionApr 7, 2026Device Markings/Labelling Problem
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE, AN UNSPECIFIED NUMBER OF TUBES WERE MISSING A LABEL, WERE BROKEN, AND THE PACKAGING WAS OPEN. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24805423 ↗MalfunctionFeb 25, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® URINE ANALYSIS PRESERVATIVE 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 24448034 ↗
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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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