BD Ultra-Fine 328291Recalls & reported problems
Becton, Dickinson and Company Inc · BD Insulin Syringes with BD Ultra-Fine Needle, U-100, 8mm, 31G, 0.3mL · Class 2
All models of BD Ultra-Fine (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30382903282914), received between Dec 9, 2022 and May 19, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).
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
- Device Contamination with Chemical or Other Material1
- Off-Label Use1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2025Off-Label Use; Device Contamination with Chemical or Other Material; Off-Label Use; Device Contamination with Chemical or Other Material
CALLER STATED, WHEN YOU PUSH ON THE PLUNGER ROD BEFORE INJECTION, SHE IS SEEING A "CLEAR LIQUID" ON THE NEEDLE TIP. LOT: 4282056 CATALOG: UNKNOWN DATE OF EVENT: UNKNOWN SAMPLES: YES PRODUCT IS BEING USED "OFF LABEL" FOR "BOTOX". CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22043891 ↗MalfunctionDec 9, 2022Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT 5 BD INSULIN SYRINGES WITH THE BD ULTRA-FINE¿ NEEDLE HAD DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MEDICAL RESEARCH LAB INJECTING MICE ASKING FOR INFORMATION ON 328291 PLUNGER HARD TO MOVE LAB TECH REPORTED USING THE SYRINGES TO INJECT HIS MICE FOR A STUDY. FINDING THE PLUNGER HARDER TO MOVE IN THIS BOX THAN A PRIOR BOX OF THE BD INSULIN SYRINGES ON 5 SYRINGES"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15947662 ↗
Other Syringe, piston devices
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- BD Luer-Lok 309653Becton, Dickinson And Company · Syringe, piston948 reports
- BD Luer-Lok 309628Becton, Dickinson And Company · Syringe, piston862 reports
- N/A 302995Becton, Dickinson And Company · Syringe, piston1 recall537 reports
- BD Plastipak Syringe 300865Becton, Dickinson And Company · Syringe, piston515 reports
- N/A 302830Becton, Dickinson And Company · Syringe, piston462 reports
- N/A 302832Becton, Dickinson And Company · Syringe, piston424 reports
- BD Ultra-Fine 328468Becton, Dickinson and Company Inc · Syringe, piston323 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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