BD Vacutainer® UltraTouch™ Push Button Blood Collection Set 367364Recalls & reported problems
Becton, Dickinson And Company · WINGSET PBBCS UTW PP 23X.75 12 LUER · Class 2
All models of BD Vacutainer UltraTouch Push Button Blood Collection Set (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Vacutainer UltraTouch push button blood collection set has 748 reports, with no deaths and 44 injuries. Many reports describe blood or fluid leaking, some from cracks in the unit, and activation that is difficult or delayed. Reports rose to 188 in the past 12 months from 85 in the 12 months 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
- 741
- Deaths reported
- 0
- Injuries reported
- 42
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 741 adverse event reports that list this exact device (DI 30382903673644), received between Oct 17, 2017 and Sep 30, 2026 — classified as 42 injuries, 699 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (222 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/Splash222
- Fluid/Blood Leak167
- Difficult or Delayed Activation151
- Product Quality Problem46
- Device Contamination with Chemical or Other Material36
- Short Fill22
- Crack20
- Material Puncture/Hole17
Patient problems
- No Clinical Signs, Symptoms or Conditions448
- No Known Impact Or Consequence To Patient182
- No Consequences Or Impact To Patient45
- Needle Stick/Puncture38
- No Patient Involvement14
- Exposure to Body Fluids13
- Blood Loss3
- No Information3
Recent adverse event reports
The 25 most recent of 741 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Activation Failure
It was reported while using BD Vacutainer® UltraTouch¿ Push Button Blood Collection Set, one (1) device had a retraction issue. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949378 ↗MalfunctionSep 29, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938986 ↗MalfunctionSep 29, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936975 ↗MalfunctionSep 29, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936968 ↗MalfunctionSep 29, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935960 ↗MalfunctionSep 28, 2026Fluid/Blood Leak; Difficult or Delayed Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923609 ↗MalfunctionSep 28, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922133 ↗MalfunctionSep 28, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922132 ↗MalfunctionSep 28, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922129 ↗MalfunctionSep 28, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922128 ↗MalfunctionSep 28, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922112 ↗MalfunctionSep 28, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921285 ↗MalfunctionSep 28, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921280 ↗MalfunctionSep 28, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918131 ↗MalfunctionSep 28, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918120 ↗MalfunctionSep 28, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915149 ↗MalfunctionSep 28, 2026Fluid/Blood Leak
Report 2 of 2It was reported that when using the BD Vacutainer® UltraTouch¿ Push Button Blood Collection Set, one (1) unit exhibited blood leakage due to a crack in the connector. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914944 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Needle Stick/Puncture
MAUDE report 50892038 ↗MalfunctionSep 24, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892035 ↗MalfunctionSep 24, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889834 ↗MalfunctionSep 21, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842460 ↗MalfunctionSep 16, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794657 ↗MalfunctionSep 15, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780208 ↗MalfunctionSep 15, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777667 ↗MalfunctionSep 15, 2026Fluid/Blood Leak
It was reported while using BD Vacutainer® UltraTouch¿ Push Button Blood Collection Set, 1 device had a crack in the female luer resulting in leakage. A repeat venipuncture was required. There was no other health impact or consequences reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50773755 ↗
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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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