BD Vacutainer® UltraTouch™ Push Button Blood Collection Set 367363Recalls & reported problems
Becton, Dickinson And Company · WINGSET PBBCS UTW PP 25X.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 77 reports, including 75 malfunctions, 2 injuries, and no deaths. Reports mostly describe leaks or splashes, delayed push-button activation, parts separating, foreign matter in packages, and 2 needlesticks. 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
- 77
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 30382903673637), received between Nov 2, 2017 and May 5, 2026 — classified as 2 injuries, 75 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (29 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/Splash29
- Difficult or Delayed Activation13
- Device Contamination with Chemical or Other Material4
- Product Quality Problem4
- Separation Problem4
- Short Fill4
- Fluid/Blood Leak3
- Material Separation3
Patient problems
- No Clinical Signs, Symptoms or Conditions47
- No Known Impact Or Consequence To Patient22
- No Consequences Or Impact To Patient3
- No Patient Involvement3
- Needle Stick/Puncture2
- Bruise/Contusion1
- No Information1
- Pain1
Recent adverse event reports
The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, BLACK FOREIGN MATTER WAS SEEN INSIDE THE TUBING OF ONE DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25082419 ↗MalfunctionApr 27, 2026Material Separation
IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE DEVICE BROKE APART WHEN THE PUSH BUTTON TO RETRACT THE NEEDLE WAS PRESSED WITH ONE (1) DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25009739 ↗InjuryMar 18, 2026Physical Resistance/Sticking
IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE NEEDLE OF ONE DEVICE DID NOT FULLY RETRACT AFTER ACTIVATING THE SAFETY MECHANISM, RESULTING IN A NEEDLESTICK INJURY. IT WAS NOT REPORTED IF ANY POST EXPOSURE TESTING OR MEDICAL INTERVENTION TOOK PLACE AS A RESULT OF THE NEEDLESTICK INJURY.
Patient problems: Needle Stick/Puncture
MAUDE report 24631538 ↗MalfunctionMar 11, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT PRIOR TO USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, BUGS WERE SEEN INSIDE OF AN UNSPECIFIED NUMBER OF UNOPENED PACKAGES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24576408 ↗MalfunctionFeb 19, 2026Material Perforation
IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, TWO (2) DEVICES HAD A HOLE IN THE TUBING AND BLOOD LEAKED FROM THE DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24395507 ↗MalfunctionFeb 9, 2026Separation Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE CANNULA OF ONE DEVICE PIERCED THE RUBBER SHEATH. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24299200 ↗MalfunctionFeb 5, 2026Leak/Splash
IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, CRACKS IN THE TUBING WERE SEEN WITH THREE DEVICES. THIS RESULTED IN SAMPLE LEAKAGE AND RECOLLECTION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24272494 ↗MalfunctionJan 21, 2026Device Damaged Prior to Receipt by User
IT WAS REPORTED THAT PRIOR TO USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE SHEATH OF ONE DEVICE FELL OFF WHEN TAKING OUT OF PACKAGING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24133374 ↗MalfunctionJan 6, 2026Separation Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, 1 DEVICE'S SPRING EJECTED OUT AFTER TAKING OFF THE NEEDLE COVER. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23985023 ↗MalfunctionDec 18, 2025Difficult or Delayed Activation; Difficult or Delayed Activation
IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, 1 DEVICE'S SPRING CAME OUT DURING COLLECTION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23837698 ↗MalfunctionDec 4, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET , AN UNSPECIFIED NUMBER OF DEVICES CAUSED BLOOD SPLATTER ON GLOVES AND HANDS WHEN ACTIVATING THE SAFETY FEATURE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23722372 ↗MalfunctionOct 28, 2025Material Separation; Material Separation
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THERE WAS ONE (1) DEVICE THAT THE SPRING POPPED OUT WHEN THE NEEDLE SHEATH WAS REMOVED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23408395 ↗MalfunctionAug 7, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE CUSTOMER NOTICED THE INFORMATION ON THE PACKAGE LABELS ARE MISPRINTED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22738553 ↗MalfunctionJul 21, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE CUSTOMER NOTICED SLEEVE SIDE PIERCING ON UNSPECIFIED NUMBER OF DEVICES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22553611 ↗MalfunctionJul 15, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT WHILE USING 4 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THERE WAS AN INK INSIDE THE PACKAGING, AND ALSO THE CUSTOMER NOTICED BLACK STAINS ON THE TUBING OF THE WINGSET. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22506918 ↗MalfunctionJun 26, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BEFORE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON, THE CUSTOMER FOUND THE NEEDLE WAS FOUND EXPOSED DUE TO PUNCTURE THROUGH ITS RUBBER COVER. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22339042 ↗MalfunctionJun 20, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, BLOOD SAMPLE LEAKAGE WAS SEEN WITH ONE DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22297452 ↗MalfunctionMar 11, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING 12 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE CUSTOMER NOTICED HOLE IN BUTTERFLY TUBING. NO PATIENT OR USER IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21574615 ↗MalfunctionMar 6, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THERE IS A HOLE IN BUTTERFLY TUBING. FOUR (4) BOXES ARE AFFECTED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21543154 ↗MalfunctionMar 5, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING 50 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, BLOOD WAS LEAKING OUT OF THE TUBING AND THE NON-PATIENT NEEDLE. NO PATIENT OR USER IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21529819 ↗MalfunctionDec 5, 2024Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT WHILE USING ONE (1) BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE PART WHERE THE NEEDLE MEETS THE PLASTIC TO CONNECT TO THE TUBING STARTED TO SQUIRT BLOOD, SO THE STAFF IMMEDIATELY ATTEMPTED TO TAKE THE NEEDLE OUT, HOWEVER, THE NEEDLE DISCONNECTED FROM THE BARREL AND WAS LEFT IN THE PATIENT ARM. IT WAS REMOVED FROM THE PATIENT AND SAMPLE WAS RECOLLECTED, NO DIRECT EXPOSURE AS BLOOD SPILLED OVER SURFACE AND ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20854410 ↗MalfunctionNov 15, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THAT THE NON-PATIENT NEEDLE PIERCED THE SIDE OF THE SLEEVE AND WAS EXPOSED ON FIVE (5) DEVICES. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20694220 ↗MalfunctionSep 6, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, BLOOD LEAKED FROM BODY OF THE DEVICE 22 TIMES, AND THE NEEDLE SEPARATED FROM THE DEVICE WHILE STILL IN PATIENT ARM ON (1) DEVICE. NO PATIENT OR USER IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20156095 ↗MalfunctionSep 5, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE DEVICE BROKE AND BLOOD LEAKED FROM THE BODY OF THE DEVICE ON (3) DEVICES. NO PATIENT OR USER IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20153949 ↗MalfunctionJun 25, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, BLOOD LEAKED FROM THE CONNECTOR TO THE HUB FOR 2 DEVICES. NO PATIENT IMPACT OR USER REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19610316 ↗
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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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