BD Vacutainer® UltraTouch™ Push Button Blood Collection Set 367365Recalls & reported problems
Becton, Dickinson And Company · WINGSET PBBCS UTW PP 21X.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 blood collection set has 249 reports on file, with no deaths and 3 injuries. Many describe fluid or blood leaking from the tubing, sometimes through a cut or hole, and some describe the push button being hard to activate. No recalls name this device, and reports rose to 132 in the latest year from 23 in the year before.
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
- 242
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 242 adverse event reports that list this exact device (DI 30382903673651), received between Nov 2, 2017 and Sep 25, 2026 — classified as 3 injuries, 239 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (105 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
- Fluid/Blood Leak105
- Leak/Splash58
- Difficult or Delayed Activation26
- Material Split, Cut or Torn13
- Short Fill9
- Device Contamination with Chemical or Other Material8
- Product Quality Problem8
- Break7
Patient problems
- No Clinical Signs, Symptoms or Conditions180
- No Known Impact Or Consequence To Patient39
- No Consequences Or Impact To Patient9
- Exposure to Body Fluids8
- Needle Stick/Puncture3
- No Information2
- Bruise/Contusion1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 242 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Device Contamination with Chemical or Other Material
It was reported that prior to using BD Vacutainer® UltraTouch¿ Push Button Blood Collection Set, the hub of one device shows signs of contamination (soiling). No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900109 ↗MalfunctionSep 24, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884789 ↗MalfunctionSep 23, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876312 ↗MalfunctionSep 23, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876311 ↗MalfunctionSep 23, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875102 ↗MalfunctionSep 23, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874607 ↗MalfunctionSep 23, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873307 ↗MalfunctionSep 23, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870506 ↗MalfunctionAug 11, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50203708 ↗MalfunctionJul 10, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25787892 ↗MalfunctionJul 8, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25756140 ↗MalfunctionJun 30, 2026Material Puncture/Hole
IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, A HOLE WAS FOUND IN 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 25666500 ↗MalfunctionJun 29, 2026Fluid/Blood Leak
REPORT 3 OF 3. IT WAS REPORTED THAT DURING BLOOD DRAW OF ONE PATIENT USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, SLEEVE LEAKAGE OCCURRED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25660072 ↗MalfunctionJun 24, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, CRACKS WERE SEEN IN THE TUBING OF AN UNSPECIFIED NUMBER OF DEVICES RESULTING 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 25612316 ↗MalfunctionJun 23, 2026Fluid/Blood Leak; Material Split, Cut or Torn
IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, 2 DEVICES WERE FOUND TO HAVE CUTS IN THE TUBING AND LEAKED BLOOD. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25600738 ↗MalfunctionJun 17, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, ONE DEVICE HAD A CRACKED LUER AND LEAKED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25537315 ↗MalfunctionJun 17, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, BLOOD LEAKED FROM 5 DEVICES IN THE PUSH BUTTON AREA. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25536353 ↗MalfunctionJun 17, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, ONE DEVICE LEAKED FROM A CRACKED LUER ONTO THE PATIENT'S HAND AND ON HEALTHCARE WORKER CLOTHES. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25533560 ↗MalfunctionJun 16, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, ONE DEVICE LEAKED FROM THE TUBING NEAR THE WING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25521550 ↗MalfunctionJun 15, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, 2 DEVICES EXHIBITED BLOOD LEAKAGE FROM THE TUBING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25505093 ↗MalfunctionJun 12, 2026Fluid/Blood Leak; Material Split, Cut or Torn
2 OF 2 REPORT. IT WAS REPORTED THAT DURING THE USE OF A BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THREE (3) UNITS WERE DISCOVERED WITH SPLIT IN THE TUBING DURING USE. NO ADVERSE PATIENT OR USER IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25493996 ↗MalfunctionJun 12, 2026Fluid/Blood Leak; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING THE USE OF A BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, AN UNSPECIFIED NUMBER OF UNITS HOLES IN TUBING, RESULTING IN LEAKAGE DURING USE. NO ADVERSE PATIENT OR USER IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25493995 ↗MalfunctionJun 12, 2026Fluid/Blood Leak; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING THE USE OF A BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, AN UNSPECIFIED NUMBER OF UNITS HAD CUT TUBING, RESULTING IN LEAKAGE DURING USE. NO ADVERSE PATIENT OR USER IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25493992 ↗MalfunctionJun 11, 2026Fluid/Blood Leak; Material Split, Cut or Torn
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, ONE (1) UNIT CONTAINED CRACKED TUBING, RESULTING IN BLOOD LEAKAGE. THERE WERE NO HEALTH IMPACTS OR CONSEQUENCES REPORTED FOR THE PATIENT OR THE USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25479035 ↗MalfunctionJun 10, 2026Fluid/Blood Leak; Material Split, Cut or Torn
IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, SAMPLE LEAKAGE OCCURRED BETWEEN THE LUER ADAPTER AND TUBING JUNCTION. THIS OCCURRED WITH 6 DEVICES RESULTING IN RECOLLECTION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25453100 ↗
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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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