Ultra-Fine 320109Recalls & reported problems
Embecta Medical II, LLC · Ultra-Fine™ Pen Needles, 8mm, 31G, 5bevel, TW · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00383017010935), received between Jan 21, 2026 and Jan 21, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
- Leak/Splash1
- Misconnection1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 21, 2026Break; Leak/Splash; Misconnection
CONSUMER REPORTED DURING INJECTION THE DOSE BUTTON STOPS AND THE INSULIN COMES OUT THE SIDE OF THE HUB. SHE COMPLETES THE FLOW CHECK WITH SUCCESS. DENIED REUSING OF NEEDLES. INFORMED CALLER OF NON PATIENT END PLACEMENT. CONSUMER REPORTED FOUND 1 PEN NEEDLE PATIENT END, SLIPPED OUT OF THE HUB AND STAYED IN HER LEG. SHE WAS ABLE TO PULL IT OUT ON HER OWN. DISCARDED SAMPLE. LOT # 5084021 FROM TEAR TAB ALL THE SAME LOT NUMBER. CATALOG# UNKNOWN, 8MM, 31G PEN NEEDLE. DATE OF EVENT UNKNOWN. SAMPLE STATUS DISCARD.
Patient problems: Foreign Body In Patient
MAUDE report 24129479 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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