BD Ultra-Fine 328289Recalls & reported problems
Becton, Dickinson and Company Inc · BD Insulin Syringes with BD Ultra-Fine Needle, U-100, 8mm, 31G, 1mL · Class 2
All models of BD Ultra-Fine (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30382903282891), received between Jun 6, 2025 and Jun 6, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 6, 2025Leak/Splash; Leak/Splash
HELLO I PURCHASED A BOX OF BD 31G 5/16 1 ML SYRINGES AND HAVE A HARD TIME PUSHING THE PLUNGER. I TRIED WORKING THE PLUNGER PRIOR TO DRAWING FLUID AND IT DOESN¿T HELP I HAVEN¿T HAD THIS PROBLEM WITH OTHER SYRINGE MANUFACTURERS I¿M VERY SURPRISED WITH THIS PRODUCT WHICH IS SUPPOSED TO BE ONE OF THE BEST. I PURCHASED THESE NEEDLES IN JAN 2025 FROM TOTAL DIABETES SUPPLY I¿M PROVIDING PICTURES OF THE BOX WITH VARIOUS NUMBERS. THE PROBLEM I¿M HAVING WITH THE NEEDLES ARE AS FOLLOWS I PRIME THE NEEDLE PRIOR TO USE TO GET THINGS MOVING SMOOTHLY AND THEN INJECT AIR INTO THE VIAL AND THEN DRAW OUT (B)(4) UNITS. I THEN INSERT THE NEEDLE IN VARIOUS PLACES THROUGHOUT THE WEEK AND HAVE PROBLEMS DEPRESSING THE PLUNGER TO INJECT THE LIQUID MEDICATION SO I¿M STUCK WITH THE NEEDLE INSERTED AND CAN¿T GET THE PLUNGER TO DISPENSE THE MEDICATION. NOW I WON¿T USE THE REMAINING NEEDLES DUE TO THESE ISSUES. THIS HAPPENED TWICE LAST WEEK MAY 5-8 2025 AND MANY TIMES PRIOR TO THOSE DATES, I HAVE 60 NEEDLES LEFT INCLUDING THE BOX. I RESEARCHED THE NEEDLE MANUFACTURERS AND BD WAS BEST BUT I¿M SORRY TO SAY I WON¿T BUY BD NEEDLES ANY LONGER. ALL THE NEEDLES I HAVE LEFT ARE UNUSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22158189 ↗
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- BD Luer-Lok 309653Becton, Dickinson And Company · Syringe, piston948 reports
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- 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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