SOL-M™ Hypodermic Needle 113005Recalls & reported problems
Sol-Millennium Medical, Inc. · Sterile hypodermic needles intended to inject fluids into, or withdraw fluids from, parts of the body below the suface of the skin. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818392015164), received between May 16, 2025 and May 16, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Component” (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
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 16, 2025Defective Component; Defective Component
"CUSTOMER REPORTED: ACCORDING TO THE END USER: " REPORTED THAT THE 30G DISPOSABLE CANNULA (HYPODERMIC NEEDLE REF: 113005 LOT 02212002) FROM SOL-M IN THE IVI SET Q4013661/9/1 HAS BEEN BLUNT FROM TIME TO TIME RECENTLY. AS PER THE CUSTOMER, THIS SHOULD NOT BE BLUNT AS IT IS USED FOR INJECTIONS INTO THE EYE. PHOTO OF THE HYPODERMIC NEEDLE ATTACHED. THE PRODUCT IS NOT AVAILABLE"". FURTHER INFORMATION FROM CUSTOMER: ""UNFORTUNATELY THE CANNULAS ARE NO LONGER THERE. WE ASSUMED THAT THE LOT NO. WAS SUFFICIENT. OUR SURGEON DR. XXXX LOOKED AT THE NEEDLE UNDER THE MICROSCOPE AND THE TIP WAS PROBABLY BENT OUTWARDS AND THEREFORE BLUNT"".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035519 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page