NovoFine® 32G Tip 185189Recalls & reported problems
Novo Nordisk Inc. · NovoFine® 32G Tip is a sterile disposable needle. · Class 2
Data updated Oct 18, 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 00301691851897), received between Nov 26, 2019 and Nov 26, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 18, 2026.
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
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.
InjuryNov 26, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
CASE DESCRIPTION: PATIENT'S WEIGHT, HEIGHT AND BODY MASS. CURRENT CONDITION: TYPE 2 DIABETES MELLITUS. INVESTIGATION RESULTS: NAME: NOVOFINE 32G TIP 6MM WITH BATCH NUMBER: 18A11K. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. THE BATCH DOCUMENTATION WAS REVIEWED. NO ABNORMALITIES RELATING TO THE OBSERVED PROBLEM WAS FOUND. A VISUAL EXAMINATION OF THE PRODUCT WAS PERFORMED. FOR NOVOFINE 32G X 6MM CARTON 8-4304-31-301-4 AS PER COMPLAINT DESCRIPTION WHERE THERE IS NO INFORMATION ABOUT HOW THE INNER NEEDLE CAP HAS TO BE REMOVED. SINCE LAST SUBMISSION THE CASE HAS BEEN UPDATED WITH THE FOLLOWING INFORMATION: -INVESTIGATIONAL RESULTS UPDATED. -MANUFACTURERS COMMENT UPDATED. NARRATIVE UPDATED ACCORDINGLY. MANUFACTURER'S COMMENT: ON 04-FEB-2020: THE DEVICE (NOVOFINE 32G 6 MM) HAS NOT BEEN RETURNED TO NOVO NORDISK A/S FOR INVESTIGATION. HOWEVER, THE USER DID INTENTIONALLY BIT THE INNER NEEDLE CAP OFF DURING WHICH THE PATIENT ACCIDENTALLY INHALED AND SWALLOWED THE CAP RESULTING IN WHISTLING SOUND WHEN TAKING A DEEP BREATH. H3 CONTINUED: EVALUATION SUMMARY: NAME: NOVOFINE 32G TIP 6MM WITH BATCH NUMBER: 18A11K. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. THE BATCH DOCUMENTATION WAS REVIEWED.
Patient problems: Foreign Body In Patient
MAUDE report 9376458 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page