BD Vacutainer® UltraTouch™ Push Button Blood Collection Set 367391Recalls & reported problems
Becton, Dickinson And Company · WINGSET PBBCS UTW PP 25X.75 7 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 is used to draw blood through a needle into tubes. The 46 reports mostly describe blood leaking or splashing from the needle, tubing or a poorly sealed sleeve, along with tubes filling short of the mark and stiff insertion; most mention no lasting effect for the patient. There are no deaths and 2 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
- 45
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 30382903673910), received between Nov 30, 2017 and Sep 14, 2026 — classified as 2 injuries, 43 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (19 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/Splash19
- Fluid/Blood Leak9
- Short Fill5
- Difficult to Insert3
- Material Deformation3
- Product Quality Problem3
- Volume Accuracy Problem3
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- No Known Impact Or Consequence To Patient4
- Discomfort3
- Needle Stick/Puncture2
- Bruise/Contusion1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
- Pain1
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763168 ↗MalfunctionSep 3, 2026Fluid/Blood Leak
Patient 2 of 2:It was reported while using BD Vacutainer® UltraTouch¿ Push Button Blood Collection Set, 1 device had a crack resulting in blood leakage. Sample was recollected. There was no other health impact or consequences reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50591118 ↗MalfunctionMay 18, 2026Fluid/Blood Leak
IT WAS REPORTED THAT DURING BLOOD COLLECTION USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, BLOOD LEAKED FROM THE NEEDLE OF TWO DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25203099 ↗MalfunctionMar 5, 2026Fluid/Blood Leak; Material Deformation
REPORT 3 OF 3: IT WAS REPORTED DURING BLOOD DRAW OF ONE PEDIATRIC PATIENT USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE TUBING WAS PERFORATED RESULTING IN SAMPLE LEAKAGE. THE PATIENT WAS SUBJECTED TO A SECOND BLOOD DRAW, WHICH CAUSED DISCOMFORT. NO ADDITIONAL ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USE.
Patient problems: Discomfort
MAUDE report 24526793 ↗MalfunctionMar 5, 2026Fluid/Blood Leak; Material Deformation
REPORT 1 OF 3. IT WAS REPORTED DURING BLOOD DRAW OF ONE PEDIATRIC PATIENT USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE SLEEVE OF ONE DEVICE WAS NOT SEALED PROPERLY RESULTING IN SAMPLE LEAKAGE. THE PATIENT WAS SUBJECTED TO A SECOND BLOOD DRAW, WHICH CAUSED DISCOMFORT. NO ADDITIONAL ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: Discomfort
MAUDE report 24526791 ↗MalfunctionMar 5, 2026Fluid/Blood Leak; Material Deformation
REPORT 2 OF 3: IT WAS REPORTED DURING BLOOD DRAW OF ONE PEDIATRIC PATIENT USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE TUBING WAS PERFORATED RESULTING IN SAMPLE LEAKAGE. THE PATIENT WAS SUBJECTED TO A SECOND BLOOD DRAW, WHICH CAUSED DISCOMFORT. NO ADDITIONAL ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: Discomfort
MAUDE report 24526790 ↗MalfunctionJan 14, 2026Fluid/Blood Leak; Difficult to Insert
IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, AN UNSPECIFIED NUMBER OF DEVICES EXHIBITED POOR SLEEVE FUNCTION LEADING TO BLOOD LEAKAGE AND INCLUDING EXCESSIVE RESISTANCE WHEN INSERTING THE TUBE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24070202 ↗MalfunctionDec 18, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, 15 DEVICES EXHIBITED POOR SLEEVE FUNCTION AND LEAKED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23837555 ↗MalfunctionNov 11, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING ONE (1) 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 23522765 ↗MalfunctionOct 24, 2025Product Quality Problem; Premature Separation; Product Quality Problem; Premature Separation
IT WAS REPORTED WHILE USING ONE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE HUB SEPARATED FROM THE DEVICE AND THE SPRING POPPED OUT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23378225 ↗MalfunctionMay 29, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE RUBBER COVERING THE NEEDLE DID NOT RETRACT PROPERLY WHEN THE TUBE IS REMOVED CAUSING BLOOD LEAKED ON MULTIPLE DEVICES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22105965 ↗MalfunctionMay 20, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE NON-PATIENT NEEDLE SLEEVE BROKE WHEN EXTRACTING THE TUBE, CAUSING BLOOD SPILLS ON UNSPECIFIED NUMBER OF DEVICES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22052791 ↗MalfunctionMay 19, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING 43 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE BLOOD FLOWED SLOW, AND THE CUSTOMER NOTICED LEAKAGE AT THE END ON THE NON-PATIENT NEEDLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22044637 ↗MalfunctionApr 17, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET AFTER DRAWING BLOOD BY PRESSING THE SAFETY SYSTEM THAT ALLOWS THE CANULA TO RETRACT, IF A DROP OF BLOOD REMAINS IN THE CANULA, SPLASHES ARE PROJECTED ONTO THE CAREGIVER. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21862909 ↗MalfunctionMar 31, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE CUSTOMER NOTICED THE NON-PATIENT SLEEVE WAS PUNCTURED AND LEAKED BLOOD IN TWO (2) DEVICES. NO PATIENT OR USER IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21730058 ↗MalfunctionMar 26, 2025Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED THAT WHILE USING ONE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, CUSTOMER NOTICED THE VACUUM WAS VERY SLOW, CAUSING THE SAMPLES TO COAGULATE OR NOT TO REACH AN OPTIMAL CAPACITY. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21702459 ↗MalfunctionMar 26, 2025Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT WHILE USING ELEVEN (11) BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE NEEDLES BROKE, AND THE NEEDLES GOT STUCK WHILE EXTRACTING THE TUBE, CAUSING BLOOD TO SPILL OUT. NO PATIENT OR USER IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21697093 ↗MalfunctionMar 26, 2025Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED THAT WHILE USING AN UNSPECIFIED NUMBER OF BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SETS, THE CUSTOMER NOTICED THE VACUUM WAS VERY SLOW FLOW, CAUSING THE SAMPLES TO COAGULATE OR NOT TO REACH AN OPTIMAL CAPACITY. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21696641 ↗MalfunctionMar 26, 2025Difficult to Insert; Leak/Splash; Difficult to Insert; Leak/Splash
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, CUSTOMER HAD DIFFICULTIES WITH THE NEEDLE AND BLOOD BEGINS TO PASS INTO THE HOLDER CAUSING SPILLS ON UNSPECIFIED NUMBER OF DEVICES. NO PATIENT OR USER IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21696640 ↗MalfunctionMar 20, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET THAT AT THE MOMENT OF CONNECTING THE TUBES TO THE VACUUM IT IS DIFFICULT TO INTRODUCE THE NEEDLE, AND THE BLOOD BEGINS TO PASS TO THE HOLDER CAUSING SPILLS. THIS OCCURRED 6 TIMES. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21657383 ↗MalfunctionFeb 20, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING FIFTY (50) BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE NON-PATIENT NEEDLE DID NOT COVER THE NEEDLE AFTER REMOVING THE TUBE CAUSING BLOOD TO SEEPS INTO BOTH THE TUBES AND THE HOLDER. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21422322 ↗MalfunctionFeb 19, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING SEVEN (7) BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE NON-PATIENT NEEDLE DID NOT COVER THE NEEDLE AFTER REMOVING THE TUBE CAUSING BLOOD TO SEEPS INTO BOTH THE TUBES AND THE HOLDER. NO PATIENT OR USER IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21417701 ↗MalfunctionFeb 19, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE NON-PATIENT NEEDLE DID NOT COVER THE NEEDLE AFTER REMOVING THE TUBE CAUSING BLOOD TO SEEP INTO BOTH THE TUBES AND THE HOLDER. NO PATIENT OR USER IMPACT REPORTED. THIS OCCURRED THREE (3) TIMES ON BATCH NUMBER 4289781 AND TWO TIMES ON UNKNOWN BATCH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21416861 ↗MalfunctionFeb 19, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING TWO (2) BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE NON-PATIENT SLEEVE DID NOT COVER THE NEEDLE AFTER REMOVING THE TUBE, CAUSING BLOOD TO LEAK INTO THE HOLDER AND ON THE PATIENT'S ARM. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21411484 ↗MalfunctionFeb 18, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING THREE (3) BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE NON-PATIENT NEEDLE DID NOT COVER THE NEEDLE AFTER REMOVING THE TUBE CAUSING BLOOD TO SEEP INTO BOTH THE TUBES AND THE HOLDER. NO PATIENT OR USER IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21403238 ↗
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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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