BD Vacutainer® Push Button Blood Collection Set 367344Recalls & reported problems
Becton, Dickinson And Company · WINGSET PBBCS 21X.75 12 LUER · Class 2
All models of BD Vacutainer Push Button Blood Collection Set (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Vacutainer push button blood collection set is used to draw blood from patients. Its 464 reports mostly describe blood leaking or splashing from the set, including onto gloves when the button is pressed. The reports include no deaths and 16 injuries, and fell to 44 in the last 12 months from 85 in the 12 months before. 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
- 464
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 464 adverse event reports that list this exact device (DI 30382903673446), received between Oct 25, 2017 and Sep 9, 2026 — classified as 16 injuries, 448 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (259 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/Splash259
- Fluid/Blood Leak67
- Difficult or Delayed Activation38
- Product Quality Problem30
- Device Contamination with Chemical or Other Material12
- Hole In Material9
- Crack8
- Detachment Of Device Component7
Patient problems
- No Clinical Signs, Symptoms or Conditions211
- No Known Impact Or Consequence To Patient187
- No Consequences Or Impact To Patient27
- No Information12
- Needle Stick/Puncture10
- No Patient Involvement9
- Exposure to Body Fluids7
- Blood Loss4
Recent adverse event reports
The 25 most recent of 464 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50692448 ↗MalfunctionJul 27, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50020810 ↗MalfunctionApr 23, 2026Fluid/Blood Leak
REPORT 2 OF 7: IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD SPLATTERED ON THE GLOVE OF THE HEALTHCARE WORKER WHEN THE SAFETY BUTTON WAS PRESSED. THIS OCCURRED 3 TIMES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24974459 ↗MalfunctionApr 23, 2026Fluid/Blood Leak
REPORT 5 OF 7: IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD SPLATTERED ON THE GLOVE OF THE HEALTHCARE WORKER WHEN THE SAFETY BUTTON WAS PRESSED. THIS OCCURRED 2 TIMES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24974358 ↗MalfunctionApr 23, 2026Fluid/Blood Leak
REPORT 1 OF 7: IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD SPLATTERED ON THE GLOVE OF THE HEALTHCARE WORKER WHEN THE SAFETY BUTTON WAS PRESSED. THIS OCCURRED 2 TIMES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24974086 ↗MalfunctionApr 23, 2026Fluid/Blood Leak
REPORT 7 OF 7: IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD SPLATTERED ON THE GLOVE OF THE HEALTHCARE WORKER WHEN THE SAFETY BUTTON WAS PRESSED. THIS OCCURRED 3 TIMES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24974064 ↗MalfunctionApr 23, 2026Fluid/Blood Leak
REPORT 6 OF 7: IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD SPLATTERED ON THE GLOVE OF THE HEALTHCARE WORKER WHEN THE SAFETY BUTTON WAS PRESSED. THIS OCCURRED 2 TIMES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24974002 ↗MalfunctionApr 23, 2026Fluid/Blood Leak
REPORT 4 OF 7: IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD SPLATTERED ON THE GLOVE OF THE HEALTHCARE WORKER WHEN THE SAFETY BUTTON WAS PRESSED. THIS OCCURRED 3 TIMES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24973880 ↗MalfunctionApr 23, 2026Fluid/Blood Leak
REPORT 3 OF 7: IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD SPLATTERED ON THE GLOVE OF THE HEALTHCARE WORKER WHEN THE SAFETY BUTTON WAS PRESSED. THIS OCCURRED 2 TIMES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24973779 ↗MalfunctionApr 13, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, FOREIGN MATTER WAS SEEN UNDER THE RUBBER SLEEVE OF ONE DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24866339 ↗MalfunctionApr 10, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE SHEATHED NEEDLE OF AN UNSPECIFIED NUMBER OF DEVICES WAS NOT GOING INTO THE VACUTAINER TUBES CORRECTLY AND CAUSING BLOOD TO LEAK OUT ALL OVER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24844581 ↗MalfunctionApr 8, 2026Activation Failure
IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, AFTER PRESSING THE RETRACTION BUTTON, THE NEEDLE ONLY RETRACTED HALFWAY. CUSTOMER HAD TO PRESS THE RETRACTION BUTTON AGAIN FOR FULL NEEDLE RETRACTION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24817972 ↗MalfunctionMar 31, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE DRAWING BLOOD FROM ONE PATIENT BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE TUBING OF THE DEVICE HAD A SMALL CUT 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 24749067 ↗MalfunctionMar 31, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD LEAKED FROM THE HUB OF THE DEVICE IN 75 DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24747741 ↗MalfunctionMar 24, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, CRACKS IN THE LUER ADAPTER WERE SEEN IN TWO DEVICES RESULTING IN SAMPLE LEAKAGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24676734 ↗MalfunctionFeb 11, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD LEAKED FROM THE NON-PATIENT END OF THE DEVICE WITH AN UNSPECIFIED NUMBER OF DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24318279 ↗MalfunctionFeb 4, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, AN UNSPECIFIED NUMBER OF DEVICES SPLASH BLOOD ONTO FINGERS AND HANDS OF HEALTHCARE WORKERS AFTER REMOVAL OF THE DEVICE FROM THE PATIENT. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24261632 ↗MalfunctionFeb 3, 2026Leak/Splash
REPORT 7 OF 11. IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD SPLATTERED DURING SAMPLE COLLECTION OF ONE PATIENT WHEN THE SAFETY DEVICE WAS ACTIVATED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24254259 ↗MalfunctionFeb 3, 2026Leak/Splash
REPORT 10 OF 11: IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD SPLATTERED DURING SAMPLE COLLECTION OF ONE PATIENT WHEN THE SAFETY DEVICE WAS ACTIVATED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24254257 ↗MalfunctionFeb 3, 2026Leak/Splash
REPORT 8 OF 11, IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD SPLATTERED DURING SAMPLE COLLECTION OF ONE PATIENT WHEN THE SAFETY DEVICE WAS ACTIVATED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24254253 ↗MalfunctionFeb 3, 2026Leak/Splash
REPORT 6 OF 11: IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD SPLATTERED DURING SAMPLE COLLECTION OF ONE PATIENT WHEN THE SAFETY DEVICE WAS ACTIVATED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24254245 ↗MalfunctionFeb 3, 2026Leak/Splash
REPORT 11 OF 11. IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD SPLATTERED DURING SAMPLE COLLECTION OF ONE PATIENT WHEN THE SAFETY DEVICE WAS ACTIVATED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24254244 ↗MalfunctionFeb 3, 2026Leak/Splash
REPORT 4 OF 11. IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD SPLATTERED DURING SAMPLE COLLECTION OF ONE PATIENT WHEN THE SAFETY DEVICE WAS ACTIVATED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24254243 ↗MalfunctionFeb 3, 2026Leak/Splash
REPORT 3 OF 11. IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD SPLATTERED DURING SAMPLE COLLECTION OF ONE PATIENT WHEN THE SAFETY DEVICE WAS ACTIVATED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24254242 ↗MalfunctionFeb 3, 2026Leak/Splash
REPORT 2 OF 11: IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD SPLATTERED DURING SAMPLE COLLECTION OF ONE PATIENT WHEN THE SAFETY DEVICE WAS ACTIVATED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24254241 ↗
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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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