BD Vacutainer® One Use Holder 364815Recalls & reported problems
Becton, Dickinson And Company · HOLDER ONE USE NONSTACKABLE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Vacutainer One Use Holder is a holder for blood collection tubes. Of its 172 reports, 8 are filed as injuries, and many describe leaks or splashes, the holder coming apart from the needle when tubes are tapped, and parts detaching. The reports mention no deaths, and 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
- 187
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 187 adverse event reports that list this exact device (DI 30382903648154), received between Nov 27, 2017 and Sep 29, 2026 — classified as 8 injuries, 179 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (46 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/Splash46
- Detachment of Device or Device Component32
- Product Quality Problem29
- Difficult to Insert12
- Material Protrusion/Extrusion12
- Fluid/Blood Leak10
- Device Markings/Labelling Problem8
- Material Deformation6
Patient problems
- No Clinical Signs, Symptoms or Conditions117
- No Known Impact Or Consequence To Patient54
- No Consequences Or Impact To Patient8
- Needle Stick/Puncture4
- Blood Loss2
- Exposure to Body Fluids1
- Hemorrhage/Blood Loss/Bleeding1
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 25 most recent of 187 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 50941157 ↗MalfunctionSep 15, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780214 ↗MalfunctionSep 10, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722241 ↗MalfunctionSep 9, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702155 ↗MalfunctionSep 9, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702154 ↗MalfunctionSep 9, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702153 ↗MalfunctionSep 9, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702152 ↗MalfunctionSep 9, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702151 ↗MalfunctionSep 9, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702150 ↗MalfunctionSep 9, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702149 ↗MalfunctionSep 9, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702148 ↗MalfunctionSep 9, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702147 ↗MalfunctionSep 9, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702146 ↗MalfunctionSep 9, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702145 ↗MalfunctionSep 9, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702144 ↗MalfunctionSep 9, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702139 ↗MalfunctionSep 9, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702137 ↗MalfunctionSep 9, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702136 ↗MalfunctionSep 9, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702135 ↗MalfunctionSep 9, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702134 ↗MalfunctionSep 9, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702133 ↗MalfunctionSep 9, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702132 ↗MalfunctionSep 9, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702121 ↗MalfunctionAug 17, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50289485 ↗MalfunctionMay 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING BLOOD DRAW OF ONE PATIENT USING BD VACUTAINER® ONE USE HOLDER, THE NEEDLE AND HOLDER UNSCREWED OR SEPARATED. THIS OCCURRED WITH THREE DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25288815 ↗
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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