BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder 367354Recalls & reported problems
Becton, Dickinson And Company · WINGSET PBBCS 23X.75 7 PREATTACHED CE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00382903673544), received between Dec 1, 2017 and Mar 7, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash2
- Break1
- Difficult or Delayed Activation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 7, 2025Difficult or Delayed Activation; Difficult or Delayed Activation
IT WAS REPORTED THAT WHILE USING TWO BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, THE NEEDLE GOT STUCK; THE CUSTOMER COULDN'T PRESS UP. NO PATIENT OR USER IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21551258 ↗MalfunctionMay 21, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, THE BLOOD FLOWED CONTINUOUSLY INTO THE BODY OF THE COLLECTION DEVICE AS SOON AS THE NEEDLE WAS INSERTED IN THE VEIN. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19359551 ↗MalfunctionDec 15, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, BLOOD SPLATTERED OUT THE IV NEEDLE END WHEN THE SAFETY FEATURE WAS ACTIVATED. BLOOD GOT ON THE PATIENT AND ON THE HEALTH PROFESSIONAL. THE HEALTH PROFESSIONAL WAS WEARING GLOVES. THE MEASURES TAKEN WERE TO SPRAY AND WASH THE AFFECTED SITE. FOUR OTHER HEALTH PROFESSIONALS EXPERIENCED THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18339647 ↗MalfunctionDec 1, 2017Break
IT WAS REPORTED THAT THE NEEDLE BROKE FROM THE REST OF THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH HOLDER 23 GAUGE 3/4 INCH NEEDLE LENGTH SAFETY NEEDLE 12 INCH TUBING DEVICE WHILE INSERTING INTO A PATIENT. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7077167 ↗
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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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