BD Vacutainer® UltraTouch™ Push Button Blood Collection Set with PAH 368689Recalls & reported problems
Becton, Dickinson And Company · UT-PBBCS 21G 12 PAH CE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 30382903686897), received between Mar 22, 2024 and Jun 25, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Leak/Splash2
- Unsealed Device Packaging2
- Device Markings/Labelling Problem1
- Fluid/Blood Leak1
- Packaging Problem1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 25, 2026Fluid/Blood Leak
REPORT 1 OF 3. IT WAS REPORTED THAT DURING BLOOD DRAW OF ONE PATIENT USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH, BLOOD LEAKING AROUND INSERTION SITE. WHEN NEEDLE WAS FURTHER ADVANCED BLOOD PROGRESSED PARTIALLY INTO THE TUBING EVEN THOUGH NO SPECIMEN TUBE WAS APPLIED/ATTACHED TO THE DEVICE. NEEDLE WAS THEN REMOVED AND PATIENT HAD TO BE STUCK AN ADDITIONAL TIME. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25621827 ↗MalfunctionMar 30, 2026Device Markings/Labelling Problem
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH, ONE (1) DEVICE WAS MISSING THE EXPIRATION DATE ON THE LABEL. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24737220 ↗MalfunctionFeb 6, 2026Break
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH, THE NEEDLES ARE BREAKING DURING USE OF AN UNSPECIFIED NUMBER OF UNITS, INCLUDING ONE INSTANCE WHERE THE REMAINED IN THE PATIENT'S ARM. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24278701 ↗MalfunctionJan 12, 2026Break
IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH, ONE (1) NEEDLE BROKEN OFF AND WAS STUCK IN THE CAP OF THE VACUTAINER TUBE. NO ADVERSE CONSEQUENCES WERE REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24035870 ↗MalfunctionJan 5, 2026Packaging Problem
IT WAS REPORTED THAT BEFORE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH, THE CUSTOMER NOTICED AN UNSPECIFIED NUMBER OF COLLECTION SET PACKAGES WERE OPEN AND NOT SEALED. NO PATIENT OR USER IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23964353 ↗MalfunctionDec 30, 2025Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD THAT BLOOD IS COMING BACK UP TO THE NEEDLE ONCE IT GETS TO THE VACUTAINER PIECE. THIS OCCURRED ONE TIME. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23923695 ↗MalfunctionNov 3, 2025Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED WHEN BEFORE THEBD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH THERE WERE AN UNSPECIFIED NUMBER OF DEVICES THAT WERE DELIVERED WITH OPEN BLISTER PACKS RENDERING THEM NON-STERILE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23452002 ↗MalfunctionOct 16, 2025Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED BEFORE USING THE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH THERE WERE 30 DEVICES THAT WERE DELIVERED WITH THE PACKAGING BLISTERS OPEN RENDING THEM NON-STERILE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23311100 ↗MalfunctionJul 29, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WITH PAH, SLEEVE LEAKAGE OCCURRED ON AN UNSPECIFIED NUMBER OF UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22644500 ↗MalfunctionMar 22, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER TUBES, BLOOD LEAKED THROUGH THE SLEEVE ON ONE DEVICE. NO PATIENT IMPACT OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18959119 ↗
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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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