BD Vacutainer® Blood Collection Tubes 366401Recalls & reported problems
Becton, Dickinson And Company · BD Vacutainer® Blood Collection Tubes · 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 30382903664017), received between Jan 5, 2018 and Feb 13, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break2
- Device Markings/Labelling Problem1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 13, 2023Break; Break
IT WAS REPORTED WHEN USING THE BD VACUTAINER® BLOOD COLLECTION TUBE THE GLASS TUBE BROKE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE GLASS BOTTOM OF THE LAVENDER BLOOD TUBE BROKE OFF."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16369525 ↗MalfunctionJun 11, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT BD VACUTAINER® BLOOD COLLECTION TUBES WERE PACKAGED WITH OTHER PRODUCTS. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7588179 ↗MalfunctionJan 5, 2018Break
IT WAS REPORTED BEFORE USE OF THE BD VACUTAINER® VENOUS BLOOD COLLECTION TUBE K3 EDTA THE GLASS TUBES WERE BREAKING AS THEY WERE BEING FILLED WITH BLOOD. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7169251 ↗
Other Tubes, vials, systems, serum separators, blood collection devices
- BD Vacutainer® SST™ 367986Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection2 recalls2,711 reports
- BD Vacutainer® Buffered Sodium Citrate (9NC) Blood Collection Tubes 363083Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1 recall1,744 reports
- BD Vacutainer® SST™ II Advance 367955Becton, Dickinson U.K. Limited · Tubes, vials, systems, serum separators, blood collection1,478 reports
- BD Vacutainer® Eclipse™ Blood Collection Needle 368607Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1,220 reports
- BD Vacutainer® SST™ 367983Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection2 recalls1,075 reports
- BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes 367856Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1,010 reports
- BD Vacutainer® PST™ Gel and Lithium HeparinN 56 Units 367960Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1 recall747 reports
- BD Vacutainer® SST™ II Advance 367957Becton, Dickinson U.K. Limited · Tubes, vials, systems, serum separators, blood collection767 reports
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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