BD Vacutainer® UltraTouch™ Push Button Blood Collection Set with PAH 368688Recalls & reported problems
Becton, Dickinson And Company · UT-PBBCS 23G 12 PAH CE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Vacutainer® UltraTouch™ Push Button Blood Collection Set with PAH is a needle set used to draw blood. The reports mostly describe blood leaking from the device during use, along with missing tube labels on some units, leading to recollection in a few cases. There are 41 reports, no deaths and no injuries. 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
- 41
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 30382903686880), received between Apr 8, 2024 and Aug 21, 2026 — classified as 41 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (22 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/Splash22
- Fluid/Blood Leak9
- Packaging Problem4
- Backflow2
- Failure to Align1
- Material Separation1
- Missing Information1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions40
- Exposure to Body Fluids1
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 21, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50374224 ↗MalfunctionJun 10, 2026Fluid/Blood Leak
3 OF 5 REPORT IT WAS REPORTED THAT WHILE USING A BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH, ONE (1) UNIT LEAKED FROM THE NEEDLE END AFTER THE NEEDLE HAS BEEN RETRACTED, RESULTING IN RECOLLECTION. NO HEALTH IMPACT OR CONSEQUENCE WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25453119 ↗MalfunctionApr 21, 2026Missing Information
IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH, AN UNSPECIFIED NUMBER OF TUBES ARE MISSING THEIR LABEL. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24943366 ↗MalfunctionApr 2, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH, BLOOD LEAKED FROM THE NON-PATIENT END OF THE DEVICE AN UNSPECIFIED NUMBER OF TIMES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24769194 ↗MalfunctionApr 2, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH, BLOOD LEAKED FROM THE NON-PATIENT END OF THE DEVICE AN UNSPECIFIED NUMBER OF TIMES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24769039 ↗MalfunctionMar 3, 2026Fluid/Blood Leak
REPORT 2 OF 2. IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH, BLOOD LEAKED FROM THE DEVICE THREE (3) TIMES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24498666 ↗MalfunctionMar 3, 2026Fluid/Blood Leak
REPORT 1 OF 2 IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH, BLOOD LEAKED FROM THE DEVICE WITH A PATIENT THREE (3) TIMES. THE PATIENT WAS STUCK AN ADDITIONAL TWO TIMES TO COMPLETE THE DRAW. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24498662 ↗MalfunctionFeb 18, 2026Leak/Splash
REPORT 1 OF 2. IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH, BLOOD LEAKED FROM THE DEVICE. A NEW DEVICE WAS SELECTED AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24384174 ↗MalfunctionFeb 18, 2026Leak/Splash
REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH, BLOOD LEAKED FROM THE DEVICE. A NEW DEVICE WAS SELECTED AND NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24384152 ↗MalfunctionJan 15, 2026Fluid/Blood Leak
REPORT 2 OF 2: IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH, BLOOD LEAKAGE OCCURRED WITH TWO (2) COLLECTION SETS. NO ADVERSE IMPACT WAS REPORTED FOR EITHER THE PATIENT OR THE USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24087055 ↗MalfunctionJan 15, 2026Fluid/Blood Leak
REPORT 1 OF 2. IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH, BLOOD LEAKAGE OCCURRED WITH TWO (2) COLLECTION SETS. NO ADVERSE IMPACT WAS REPORTED FOR EITHER THE PATIENT OR THE USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24087028 ↗MalfunctionJan 15, 2026Fluid/Blood Leak
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH, BLOOD LEAKAGE OCCURRED IN AN UNSPECIFIED NUMBER OF COLLECTION SETS. NO ADVERSE IMPACT WAS REPORTED FOR EITHER THE PATIENT OR THE USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24084387 ↗MalfunctionDec 18, 2025Backflow; Backflow
IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH, THAT BLOOD IS BACKFLOWING TO THE NEEDLE ONCE IT GETS TO THE VACUTAINER TUBE. THIS OCCURRED ONE TIME. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23845130 ↗MalfunctionNov 6, 2025Failure to Align; Failure to Align
IT WAS REPORTED BEFORE USING ONE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET THE NON-PATIENT CANNULA HAD PIERCED THE SIDE OF THE SLEEVE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23486940 ↗MalfunctionOct 16, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHEN USING THE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH THERE WAS DAMAGE TO THE TUBING, RESULTING IN LEAKAGE IN 6 DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23310817 ↗MalfunctionAug 6, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH, BLOOD LEAKED INTO THE HOLDER ON UNSPECIFIED NUMBER OF DEVICES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22730390 ↗MalfunctionMay 14, 2025Backflow; Leak/Splash; Backflow; Leak/Splash
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH, THE CUSTOMER NOTICED THE BLOOD WAS FLOWING SLOWLY INTO THE TUBE, THEN BEGAN BACKFLOWING INTO THE VEIN, AND WHEN THE NEEDLE WAS RETRACTED, THE BLOOD LEAKED ALL OVER THE PATIENT AND THE BED. RECOLLECTION WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22021937 ↗MalfunctionMay 6, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD, THE CUSTOMER NOTICED THE DEVICE WAS LEAKING BLOOD ON UNSPECIFIED NUMBER OF DEVICES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21973303 ↗MalfunctionMar 12, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH, BLOOD SQUIRTED OUT FROM THE TUBE AND WAS LEAKING. NO PATIENT OR USER IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21585848 ↗MalfunctionMar 7, 2025Short Fill; Short Fill
IT WAS REPORTED THAT WHILE USING WHILE USING ONE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH, BLOOD STARTED FLOWING INTO THE GOLD TOP TUBE VERY SLOWLY, THEN IT STARTED FLOWING BACK TO THE PATIENT. NO PATIENT OR USER IMPACT REPORTED AS THE NURSE REMOVED THE VACUTAINER TUBE, DISCONNECTED THE TRANSFER DEVICE FROM THE BUTTERFLY TUBING, AND ATTACHED THE 3 ML SYRINGE TO THE BUTTERFLY TUBING TO MANUALLY WITHDRAW THE BLOOD THROUGH THE BUTTERFLY TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21548878 ↗MalfunctionFeb 13, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING ONE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH, BLOOD LEAKED FROM WHERE THE NEEDLE IS RETRACTED. NO PATIENT OR USER IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21378888 ↗MalfunctionFeb 6, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH THAT TWO (2) DEVICES LEAKED FROM THE RETRACTED NEEDLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21326593 ↗MalfunctionFeb 5, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH, BLOOD STARTED LEAKING OUT WHEN THE NEEDLE WAS RETRACTED. THIS HAS OCCURRED TWO (2) TIMES AND NO PATIENT OR USER IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21313445 ↗MalfunctionFeb 5, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH THAT TWO (2) DEVICES LEAKED FROM THE RETRACTED NEEDLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21312698 ↗MalfunctionFeb 4, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH THAT AN UNSPECIFIED NUMBER OF DEVICES LEAKED FROM THE RETRACTED NEEDLE OPENING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21305523 ↗
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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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