BD Ultra-Fine 320881Recalls & reported problems
Becton Dickinson Pen Limited · BD Ultra-Fine Pen Needles, 8mm, 31G, 5bevel, TW · Class 2
All models of BD Ultra-Fine (4)
Data updated Oct 18, 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 00382903208814), received between Nov 25, 2020 and Dec 7, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (2 reports).
1 other recall cover devices cleared under the same FDA submission (K213478); they may or may not involve this specific model.
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
- Failure to Deliver2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 7, 2020Failure to Deliver; Failure to Deliver
IT WAS REPORTED THAT 2 BD ULTRA FINE¿ III PEN NEEDLES WERE BLOCKED AND FAILED TO DELIVER MEDICINE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD ULTRA FINE SHORT PEN NEEDLES, LOT# 8360689, HARM/ INJURY : NONE. PEN NEEDLE WAS BLOCKED X 2"
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10962119 ↗MalfunctionNov 25, 2020Failure to Deliver; Failure to Deliver
IT WAS REPORTED THAT PEN NDL 31G 8MM 90 COUNT MAIL ORDER ONLY HAD NO INSULIN FLOW. THIS OCCURRED ON 10 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:320881 BATCH NO: 9114901. IT WAS REPORTED THAT THE INSULIN DOES NOT FLOW AND THE PATIENT END WILL NOT ATTACH TO THE INSULIN PEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10906802 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K213478. One submission often covers many models, so check the product and lot details in each record.
- Z-3180-2026 · Jul 26, 2023 · Open, ClassifiedEWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100
Other Needle, hypodermic, single lumen devices
- BD Nano 2nd Gen 320550Becton Dickinson Pen Limited · Needle, hypodermic, single lumen2,044 reports
- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 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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