BD Vacutainer® No Additive (Z) Plus Tubes 366408Recalls & reported problems
Becton, Dickinson And Company · Tube Urin PLH 13x100mm 6.0ml UA PLBL CR · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
These are BD Vacutainer urine collection tubes used to collect and transport patient samples. The 45 reports mostly describe caps and stoppers that won't stay on, come off during transport and cause spills or leaks, and tubes that are hard to open or won't draw urine in. No deaths or injuries were reported. There are no recalls for 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
- 45
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 30382903664086), received between Feb 11, 2020 and Jun 9, 2026 — classified as 45 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (20 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
- Leak/Splash20
- Difficult to Remove9
- Device Contamination with Chemical or Other Material3
- Separation Failure3
- Separation Problem3
- Premature Separation2
- Short Fill2
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions44
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 9, 2026Device Markings/Labelling Problem
IT WAS REPORTED WHEN USING THE BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES, ONE (1) TUBE WAS MISSING LABEL. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25446081 ↗MalfunctionMay 21, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES, AN UNSPECIFIED NUMBER OF TUBES TUBES ARE NOT DRAWING URINE INTO TUBES WITH GOOD VACUUM. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25249503 ↗MalfunctionDec 1, 2025Premature Separation; Premature Separation
IT WAS REPORTED DURING USE OF BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES, AN UNSPECIFIED NUMBER OF TUBES HAD A LOOSE CLOSURE AFTER REMOVING THE CAP AND REPLACING IT RESULTING IN SAMPLE LEAKAGE. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23688415 ↗MalfunctionJul 28, 2025Premature Separation; Premature Separation
IT WAS REPORTED WHILE USING BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES, 20 TUBES HAD STOPPERS THAT WERE LOOSE AND WOULD NOT STAY ON THE TUBES AFTER INITIAL REMOVAL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22639215 ↗MalfunctionJun 4, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES, AN UNSPECIFIED NUMBER OF TUBES HAVE CAP ISSUES WHERE THE CAP CANNOT BE PLACED PROPERLY BACK ON THE TUBE AFTER REMOVING THE CAP. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22142894 ↗MalfunctionMay 29, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED DURING TRANSPORT OF BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBE, AN UNSPECIFIED NUMBER OF STOPPERS ARE POPPING OFF DURING TRANSPORT CAUSING SPILLS. CUSTOMER IS REMOVING THE STOPPER, ALIQUOTING SAMPLE, AND THEN REPLACING STOPPER. SAMPLES WERE RECOLLECTED. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22110569 ↗MalfunctionMay 29, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED DURING TRANSPORT OF BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBE, AN UNSPECIFIED NUMBER OF STOPPERS ARE POPPING OFF DURING TRANSPORT CAUSING SPILLS. CUSTOMER IS REMOVING THE STOPPER, ALIQUOTING SAMPLE, AND THEN REPLACING STOPPER. SAMPLES WERE RECOLLECTED. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22106701 ↗MalfunctionMay 14, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES FOR ALIQUOTS, AN UNSPECIFIED NUMBER OF TUBES HAVE STOPPERS THAT ARE NOT STAYING ON AFTER STOPPER IS REMOVED AND RE-APPLIED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22021922 ↗MalfunctionMay 14, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES FOR ALIQUOTS, AN UNSPECIFIED NUMBER OF TUBES HAVE STOPPERS THAT ARE NOT STAYING ON AFTER STOPPER IS REMOVED AND RE-APPLIED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22021509 ↗MalfunctionMar 7, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES, AN UNSPECIFIED NUMBER OF TUBES EXHIBIT CORING OF THE STOPPER AFTER PIERCING OF THE TUBE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21547839 ↗MalfunctionMar 6, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES, AN UNSPECIFIED NUMBER OF CAPS ARE NOT STAYING ON WHEN REPLACED FOR SAMPLING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21536561 ↗MalfunctionMar 5, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES, AN UNSPECIFIED NUMBER OF CAPS ARE NOT STAYING ON WHEN REPLACED FOR SAMPLING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21526025 ↗MalfunctionFeb 12, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES, AN UNSPECIFIED NUMBER OF TUBES EXHIBITED CLOSURE SEPARATION ON THEIR AUTOMATED INSTRUMENT WHERE THE SHIELD WAS REMOVED BUT THE STOPPER REMAINED IN THE TUBE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21370279 ↗MalfunctionJan 28, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED DURING USE OF BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES, AN UNSPECIFIED NUMBER OF CAPS ARE POPPING OFF DURING TRANSPORT AND SPILLING. THESE TUBES ARE BEING USED FOR ALIQUOTS AND THE CAPS ARE NOT STAYING ON AFTER BEING REAPPLIED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21258678 ↗MalfunctionJan 28, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED DURING USE OF BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES, AN UNSPECIFIED NUMBER OF CAPS ARE POPPING OFF DURING TRANSPORT AND SPILLING. THESE TUBES ARE BEING USED FOR ALIQUOTS AND THE CAPS ARE NOT STAYING ON AFTER BEING REAPPLIED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21258669 ↗MalfunctionJan 27, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED DURING USE OF BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES, AN UNSPECIFIED NUMBER OF CAPS ARE POPPING OFF DURING TRANSPORT AND SPILLING. THESE TUBES ARE BEING USED FOR ALIQUOTS AND THE CAPS ARE NOT STAYING ON AFTER BEING REAPPLIED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21246193 ↗MalfunctionJan 27, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED DURING USE OF BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES, AN UNSPECIFIED NUMBER OF CAPS ARE POPPING OFF DURING TRANSPORT AND SPILLING. THESE TUBES ARE BEING USED FOR ALIQUOTS AND THE CAPS ARE NOT STAYING ON AFTER BEING REAPPLIED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21246192 ↗MalfunctionJan 27, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED DURING USE OF BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES, AN UNSPECIFIED NUMBER OF CAPS ARE POPPING OFF DURING TRANSPORT AND SPILLING. THESE TUBES ARE BEING USED FOR ALIQUOTS AND THE CAPS ARE NOT STAYING ON AFTER BEING REAPPLIED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21244454 ↗MalfunctionJan 22, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED DURING USE OF BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES, AN UNSPECIFIED NUMBER OF TUBES HAD A LOOSE CLOSURE AND EASILY FALL OFF. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21211216 ↗MalfunctionJan 14, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES, 2 TUBES CONTAINED FOREIGN MATTER(FM), DARK BROWN SOOT WAS OBSERVED INSIDE THE BOTTOM OF THE TUBES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21148948 ↗MalfunctionJan 7, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED DURING USE OF BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES, AN UNSPECIFIED NUMBER OF TUBES HAD LOOSE CAPS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21092750 ↗MalfunctionDec 13, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES, AN UNSPECIFIED NUMBER OF STOPPERS SEPARATED FROM THE SHIELD DURING CAP REMOVAL ON THEIR AUTOMATED INSTRUMENT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20924604 ↗MalfunctionDec 9, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES, AN UNSPECIFIED NUMBER OF STOPPERS SEPARATED FROM THE SHIELD DURING CAP REMOVAL ON THEIR AUTOMATED INSTRUMENT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20886905 ↗MalfunctionDec 9, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED DURING USE OF BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES, AN UNSPECIFIED NUMBER OF STOPPERS ARE POPPING OF THE TUBES DURING TRANSPORT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20881046 ↗MalfunctionNov 29, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES, THE STOPPER POPS OFF OF 20 TUBES. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18232451 ↗
Other CONTAINER, SPECIMEN, STERILE devices
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- BD Vacutainer® No Additive (Z) Tubes 366703Becton, Dickinson And Company · CONTAINER, SPECIMEN, STERILE143 reports
- Medline Industries, Inc. DYNJ63118AMedline Industries, Inc. · CONTAINER, SPECIMEN, STERILE2 recalls0 reports
- MyCareLink Smart™ 25000Medtronic, Inc. · CONTAINER, SPECIMEN, STERILE1 recall5 reports
- Centurion MG912STCenturion Medical Products Corporation · CONTAINER, SPECIMEN, STERILE1 recall0 reports
- Vacuette 450225Greiner Bio-One GmbH · CONTAINER, SPECIMEN, STERILE1 recall0 reports
- Medline Industries, Inc. DYNJ905664IMedline Industries, Inc. · CONTAINER, SPECIMEN, STERILE1 recall0 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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