BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder 367355Recalls & reported problems
Becton, Dickinson And Company · WINGSET PBBCS 21X.75 7 PREATTACHED CE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00382903673551), received between Mar 21, 2025 and Apr 4, 2025 — classified as 3 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
- Crack1
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 4, 2025Crack; Leak/Splash; Crack; Leak/Splash
IT WAS REPORTED THAT WHILE USING ONE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, THE CUSTOMER NOTICED LEAKAGE AT THE CRACKED CONNECTOR. NO PATIENT OR USER IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21775372 ↗MalfunctionMar 24, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE BEFORE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, THE CUSTOMER NOTICED THE PACKAGED STERILITY SEAL WAS DAMAGED ON ALL 5 BOXES. NO PATIENT OR USER IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21683809 ↗MalfunctionMar 21, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING ONE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, THERE WAS A LEAKED AT THE CRACKED CONNECTOR. NO CLINICAL CONSEQUENCES FOR THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21664900 ↗
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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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