BD Nano Ultra-Fine 320883Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00382903208838), received between Dec 4, 2020 and Apr 16, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (3 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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2021Failure to Deliver; Failure to Deliver

  IT WAS REPORTED WHILE USING BD NANO¿ ULTRA-FINE¿ PEN NEEDLES, 32G X 4MM MAIL ORDER INSULIN WAS UNABLE TO BE COMPLETELY DELIVERED DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT INSULIN STOPPED FLOWING DURING INJECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11681891 ↗
• MalfunctionApr 15, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT CONSUMER FOUND UNOPENED BD NANO¿ ULTRA-FINE¿ PEN NEEDLES, 32G X 4MM AND THE EXPIRATION DATES WERE MISSING ON SHELF CARTONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CONSUMER DISCOVERED THERE WERE NO EXPIRATION DATES ON SHELF CARTONS. LOT # 4302119 & 4198428.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11675958 ↗
• MalfunctionMar 26, 2021Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE PEN NDL 32G 4MM WAS UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED ---FINDING FROM THIS BOX 1 OUT OF EVERY 2-3 PEN NEEDLES CLOG DURING INJECTION VERIFIED THE LOT NUMBER AND OBTAINED THE ITEM # FROM THE BOX. THIS USER IS ALSO A DOCTOR WHO HAS MEDICAL PRACTICE AT HOME ADDRESS. REVIEWED PLACEMENT OF PEN NEEDLES ONTO THE PEN AND TO COMPLETE A FLOW CHECK WITH EACH INJECTION. CONSUMER RESISTANT TO COMPLETING THIS PROCESS. LOT #: 8360678. CATALOG#: 320883. DATE OF EVENT: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11575646 ↗
• MalfunctionDec 4, 2020Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY WAS CLOGGED DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320883 BATCH NO. 9183109. IT WAS REPORTED THAT NEEDLE CLOGS DURING INJECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10944194 ↗

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, Classified
  EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100