BD Ultra-Fine 328440Recalls & reported problems
Becton, Dickinson and Company Inc · BD Insulin Syringes with BD Ultra-Fine Needle, U-100, 8mm, 31G, 0.3mL, 1/2 unit · Class 2
Quick summary
This BD Ultra-Fine insulin syringe has a very fine needle. Its 186 reports include no deaths and 5 injuries. Many describe liquid leaking from the barrel, scale markings that are inaccurate or hard to read, and needles that are bent or have residue on them. There are no reports in the last 12 months, compared with 6 in the prior 12 months, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 209
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 209 adverse event reports that list this exact device (DI 00382908440035), received between Nov 1, 2017 and Sep 30, 2026 — classified as 5 injuries, 204 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (59 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash59
- Volume Accuracy Problem57
- Device Contamination with Chemical or Other Material22
- Failure to Deliver19
- Device Markings/Labelling Problem17
- Defective Device11
- Break5
- Complete Blockage3
Patient problems
- No Clinical Signs, Symptoms or Conditions90
- No Known Impact Or Consequence To Patient60
- No Consequences Or Impact To Patient44
- No Patient Involvement8
- Purulent Discharge4
- Abscess3
- Erythema3
- Rash3
Recent adverse event reports
The 25 most recent of 209 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946521 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946374 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946143 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945952 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945699 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945586 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945332 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945228 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
0.3cc 31G Syr.10*10 8mm 100'S/BX ¿¿:3219230, It has been opened. The customer reported that the product quantity was 88 pieces and the scale was inaccurate. (Buy a box of 100 pieces)tmaik 19September2024 additional information attachedMaterial: Item number: 0.3cc 31G Syr.10*10 8mm 100'S/BX Batch number: 3219230.reason:Consumer printing accuracy questionable(Consumers believe that the printing accuracy of 88 out of 100 purchased in a box is questionable)Current status:1) Consumers only provide photos, quantities and batch numbers, so they can only upload current information.2) Whether the customer has communicated with the consumer or not is a subjective factor of personal judgment.3) The customer contacted the consumer about the batch number, but the consumer did not call back.Second email info attachment:1) The batch number 3219230 is correctly linked to the catalog number 328440.Because the model number was not filled in on the customer letter (as shown below),The product number was verbally reported incorrectly during the telephone inquiry, and was subsequently reconfirmed to be 328440.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945019 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944485 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944354 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944162 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943921 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943657 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943569 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
0.3cc 31G Syr.10*10 8mm 100'S/BX ¿¿:3219230, It has been opened. The customer reported that the product quantity was 88 pieces and the scale was inaccurate. (Buy a box of 100 pieces)(b)(6) 2024 additional information attachedMaterial: Item number: 0.3cc 31G Syr.10*10 8mm 100'S/BX Batch number: 3219230.reason:Consumer printing accuracy questionable(Consumers believe that the printing accuracy of 88 out of 100 purchased in a box is questionable).Current status:1) Consumers only provide photos, quantities and batch numbers, so they can only upload current information.2) Whether the customer has communicated with the consumer or not is a subjective factor of personal judgment.3) The customer contacted the consumer about the batch number, but the consumer did not call back.Second email info attachment:1) The batch number 3219230 is correctly linked to the catalog number 328440.Because the model number was not filled in on the customer letter (as shown below),The product number was verbally reported incorrectly during the telephone inquiry, and was subsequently reconfirmed to be 328440.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943453 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943346 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943279 ↗MalfunctionSep 30, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943033 ↗MalfunctionSep 29, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935709 ↗MalfunctionSep 29, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935162 ↗MalfunctionSep 29, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934851 ↗MalfunctionSep 29, 2026Volume Accuracy Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934367 ↗MalfunctionMar 28, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
CONSUMER REPORTED LIQUID INSIDE OF THE BARREL OF HIS SYRINGES. HE STATED THAT WHEN HE DEPRESSED THE PLUNGER ROD, HE NOTICED THE LIQUID COMING OUT. CONSUMER STATED THAT THE BAG WAS SEALED. LOT #: 4191017, CATALOG #: 328440, DATE OF EVENT: UNKNOWN, SAMPLES: AVAILABLE - SENDING MAIL KIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21726842 ↗MalfunctionMar 10, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
DIFFERENT PRODUCT RECEIVED: 15 BOXES OF BD ULTRA FINE NEEDLE - 8MM 31 GAUGE WERE FOUND IN THE CARTON OF INSULIN BD SYRINGES 1.0ML 30GA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21560016 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.