BD Vacutainer® Push Button Blood Collection Set 367338Recalls & reported problems
Becton, Dickinson And Company · WINGSET PBBCS 21X.75 7 LUER · Class 2
All models of BD Vacutainer Push Button Blood Collection Set (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BD Vacutainer push button blood collection set is used to draw blood. It has 198 adverse event reports, with no deaths and 3 injuries, plus 195 malfunctions. Many describe blood or fluid leaking and parts detaching from the tubes, and some describe blood splatter. 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
- 194
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 194 adverse event reports that list this exact device (DI 30382903673385), received between Nov 2, 2017 and Sep 29, 2026 — classified as 2 injuries, 192 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (70 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash70
- Fluid/Blood Leak43
- Crack17
- Detachment of Device or Device Component17
- Difficult or Delayed Activation9
- Hole In Material8
- Device Markings/Labelling Problem7
- Device Contamination with Chemical or Other Material5
Patient problems
- No Clinical Signs, Symptoms or Conditions106
- No Known Impact Or Consequence To Patient54
- No Consequences Or Impact To Patient19
- Exposure to Body Fluids10
- Device Embedded In Tissue or Plaque1
- Discomfort1
- Erythema1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 25 most recent of 194 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936983 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936973 ↗MalfunctionSep 16, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793764 ↗MalfunctionAug 20, 2026Crack; Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50356703 ↗MalfunctionJun 12, 2026Detachment of Device or Device Component
1 OF 2 REPORT. IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, UNSPECIFIED NUMBER OF UNITS GRADUALLY DETACHED / UNSCREW DURING USE FROM TUBES. NO PATIENT OR USER IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25492212 ↗MalfunctionJun 12, 2026Detachment of Device or Device Component
2 OF 2 REPORT. IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, UNSPECIFIED NUMBER OF UNITS GRADUALLY DETACHED / UNSCREW DURING USE FROM TUBES. NO PATIENT OR USER IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25492162 ↗MalfunctionMay 26, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION, THE NEEDLE OF AN UNSPECIFIED NUMBER OF DEVICES RETRACTS WHILE IN THE VEIN RESULTING IN BLOOD SPLATTER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25280289 ↗MalfunctionMay 20, 2026Premature Separation
PATIENT 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE HOLDER AND WINGSET OF ONE DEVICE SEPARATED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25230059 ↗MalfunctionMay 20, 2026Premature Separation
PATIENT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE HOLDER AND WINGSET OF ONE DEVICE SEPARATED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25230058 ↗MalfunctionMay 18, 2026Detachment of Device or Device Component
IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE WINGSET AND HOLDER BECAME DETACHED WHILE COLLECTING THE FIFTH TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25208000 ↗MalfunctionMay 14, 2026Crack; Fluid/Blood Leak; Material Deformation
IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, 1 DEVICE HAD A CRACK IN THE FEMALE LUER AND LEAKED. AN INSPECTION OF ANOTHER DEVICE SHOWED A CRACK IN THE FEMALE LUER AS WELL AS A MOLDING DEFECT BETWEEN THE MALE LUER AND CANNULA. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25177768 ↗MalfunctionMay 5, 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 ONE (1) PATIENT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25086644 ↗MalfunctionMay 5, 2026Detachment of Device or Device Component
IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE HOLDER UNSCREWS FROM THE NEEDLE EACH TIME A TUBE IS CONNECTED. THIS OCCURRED 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 25083896 ↗MalfunctionMay 1, 2026Detachment of Device or Device Component
REPORT 1 OF 2. IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE NEEDLE SEPARATED FROM THE HOLDER. THIS OCCURRED 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 25059119 ↗MalfunctionMay 1, 2026Detachment of Device or Device Component
REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE NEEDLE SEPARATED FROM THE HOLDER. THIS OCCURRED 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 25059116 ↗MalfunctionMay 1, 2026Detachment of Device or Device Component
IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE NEEDLE SEPARATED FROM THE HOLDER. THIS OCCURRED 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 25059107 ↗MalfunctionApr 24, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, BLOOD LEAKED FROM A CRACK IN THE LUER OF ONE (1) DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24984194 ↗MalfunctionApr 23, 2026Detachment of Device or Device Component
IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE NEEDLE AND HOLDER SEPARATED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24966939 ↗MalfunctionApr 22, 2026Fluid/Blood Leak; Premature Separation
REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, CRACKS WERE SEEN IN THE LUER ADAPTER OF AN UNSPECIFIED NUMBER OF DEVICES RESULTING IN SAMPLE LEAKAGE. ADDITIONALLY, AN UNSPECIFIED NUMBER OF DEVICES ARE EXHIBITING NEEDLE AND HOLDER SEPARATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24960552 ↗MalfunctionApr 22, 2026Fluid/Blood Leak; Premature Separation
REPORT 2 OF 2. IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, CRACKS WERE SEEN IN THE LUER ADAPTER OF AN UNSPECIFIED NUMBER OF DEVICES RESULTING IN SAMPLE LEAKAGE. ADDITIONALLY, AN UNSPECIFIED NUMBER OF DEVICES ARE EXHIBITING NEEDLE AND HOLDER SEPARATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24959823 ↗MalfunctionApr 17, 2026Fluid/Blood Leak
IT WAS REPORTED THAT DURING BLOOD COLLECTION OF A PATIENT USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE FEMALE LUER ADAPTER OF ONE DEVICE WAS CRACKED RESULTING IN SAMPLE LEAKAGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912799 ↗MalfunctionApr 16, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THAT THE WINGSET BECAME DISENGAGED WITH THE COLLECTION TUBE. THIS OCCURRED IN ONE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24897423 ↗MalfunctionApr 15, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE NEEDLE FAILED TO RETRACT WHEN THE BUTTON WAS PRESSED RESULTING IN SAMPLE LEAKAGE AND EXPOSURE. THE NURSE FOLLOWED PROTOCOL FOR ACCIDENTAL EXPOSURE TO BLOOD. THERE IS NO REPORT TO WHAT EXTENT EXPOSURE OCCURRED NOR WHAT SITE PROTOCOL CONSISTED OF.
Patient problems: Exposure to Body Fluids
MAUDE report 24889120 ↗MalfunctionApr 9, 2026Detachment of Device or Device Component
IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE SAMPLING BODY UNSCREWED OR DISCONNECTED COMPLETELY FROM THE WING WHEN THE TUBES WERE INSERTED. THIS OCCURRED WITH ONE DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24835147 ↗MalfunctionApr 3, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE HUB OF ONE DEVICE WAS CRACKED RESULTING IN SAMPLE LEAKAGE AND RECOLLECTION. BLOOD GOT ONTO THE HEALTHCARE WORKERS HANDS. THERE IS NO REPORT OF THE LEVEL OF PPE WORN, POST EXPOSURE TESTING OR MEDICAL INTERVENTION.
Patient problems: Exposure to Body Fluids
MAUDE report 24781968 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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