BD Vacutainer® Push Button Blood Collection Set 367342Recalls & reported problems
Becton, Dickinson And Company · WINGSET PBBCS 23X.75 12 LUER · Class 2
Quick summary
This BD Vacutainer Push Button blood collection set has 791 FDA reports: 731 malfunctions, 60 injuries and no deaths. Many reports describe blood leaking from cracked connectors, while others mention difficult activation, short fills and breakage, and some mention needle sticks. There are no recalls naming this device. Reports rose from 71 in the previous 12 months to 161 in the most recent 12 months.
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
- 781
- Deaths reported
- 0
- Injuries reported
- 60
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 781 adverse event reports that list this exact device (DI 30382903673422), received between Oct 20, 2017 and Sep 30, 2026 — classified as 60 injuries, 721 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (235 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash235
- Fluid/Blood Leak170
- Difficult or Delayed Activation81
- Product Quality Problem53
- Short Fill42
- Break35
- Retraction Problem30
- Volume Accuracy Problem29
Patient problems
- No Clinical Signs, Symptoms or Conditions353
- No Known Impact Or Consequence To Patient273
- No Consequences Or Impact To Patient78
- Needle Stick/Puncture58
- No Patient Involvement10
- Exposure to Body Fluids8
- No Information6
- Hemorrhage/Blood Loss/Bleeding3
Recent adverse event reports
The 25 most recent of 781 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Difficult or Delayed Activation
It was reported that after using the BD Vacutainer® Push Button Blood Collection Set, one (1) unit exhibited difficulty in retracting the needle. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946954 ↗MalfunctionSep 29, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935966 ↗MalfunctionSep 29, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935052 ↗MalfunctionSep 29, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935041 ↗MalfunctionSep 29, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933758 ↗MalfunctionSep 15, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780203 ↗MalfunctionSep 14, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764379 ↗MalfunctionSep 14, 2026Fluid/Blood Leak; Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763171 ↗MalfunctionSep 14, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761287 ↗MalfunctionSep 11, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50733219 ↗MalfunctionAug 20, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50352495 ↗MalfunctionJul 28, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50060190 ↗MalfunctionJul 9, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25766414 ↗MalfunctionJul 6, 2026Material Deformation
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD WAS LEAKING FROM A CRACK IN THE HUB OF THREE (3) UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25725111 ↗MalfunctionJun 18, 2026Crack; Fluid/Blood Leak
IT WAS REPORTED DURING BLOOD COLLECTION WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, 6 DEVICES LEAKED AND A CRACKED LUER WAS FOUND UPON INSPECTION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25552916 ↗MalfunctionJun 17, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, AN UNSPECIFIED NUMBER OF DEVICES HAVE CRACKED LUERS AND ARE LEAKING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25540098 ↗MalfunctionJun 17, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, AN UNSPECIFIED NUMBER OF DEVICES HAVE CRACKED LUERS AND ARE LEAKING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25537318 ↗MalfunctionJun 15, 2026Fluid/Blood Leak; Material Split, Cut or Torn
IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, 1 DEVICE LEAKED BLOOD OUT OF THE TUBING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25504159 ↗MalfunctionJun 12, 2026Device Markings/Labelling Problem; Missing Information
1 OF 2 REPORT. IT WAS REPORTED THAT WHEN USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, TWO (2) UNITS WERE MISSING EXPIRATION DATE ON THE LABEL. NO HEALTH IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25493993 ↗MalfunctionMay 26, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD LEAKED FROM A CRACK IN THE LUER OF 2 DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25289530 ↗MalfunctionMay 26, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THERE'S A CRACK IN THE HUB RESULTING IN SAMPLE LEAKAGE. THIS OCCURRED WITH FIVE DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25284138 ↗MalfunctionMay 26, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THERE'S A CRACK IN THE HUB RESULTING IN SAMPLE LEAKAGE. THIS OCCURRED WITH TWO DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25280315 ↗MalfunctionMay 20, 2026Material Separation
IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE SPRING POPPED OUT WHEN ACTIVATING THE SAFETY FEATURE TO RETRACT THE NEEDLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25234390 ↗MalfunctionMay 19, 2026Premature Activation
IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE NEEDLE WAS INSERTED INTO THE ARM. WHEN THE NURSE WENT TO ADVANCE THE NEEDLE, THE SAFETY DEVICE ACTIVATED AND THE NEEDLE RETRACTED. THE NURSE DID NOT ACTIVATE SAFETY MECHANISM OR BUMP IT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25219139 ↗MalfunctionMay 11, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, AN UNSPECIFIED NUMBER OF DEVICES HAD HOLES IN THE TUBING RESULTING IN TUBES NOT BEING FILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25142791 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.