SOL-M™ Hypodermic Needle 112506Recalls & 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
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818392015140), received between May 16, 2025 and May 16, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility1
- Dull, Blunt1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 16, 2025Dull, Blunt; Dull, Blunt
IT WAS REPORTED: ACCORDING TO BASTOS VIEGAS, DIFFICULTY WHEN PENETRATING THE SKIN. USED IN LOCAL ANESTHESIA AND SCLEROTHERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035526 ↗MalfunctionMay 16, 2025Device-Device Incompatibility; Device-Device Incompatibility
"INCIDENT DESCRIPTION: DURING DIRECT INTRAVENOUS INJECTION OF RADIOPHARMACEUTICAL MEDICINE, HEALTHCARE PROVIDER NOTES THAT NEEDLE IS BIASED IN ITS CAP. IT'S ALSO HARD TO SCREW THE NEEDLE HUB ON SYRINGES, ESPECIALLY THE LUER-LOCK 2.5 ML REF (B)(4) MANUFACTURED BY TERUMO, AND ALSO THE LUER-LOCK PLASTIPAK 5ML REF (B)(4) AND 10ML (B)(4) BECTON DICKINSON MANUFACTURER. IT HAS BEEN NOTED THAT NEEDLES WERE OFTEN SIDEWAYS IN THEIR PROTECTIVE CAPS, THAT THEY WERE VERY SOFT AND THERE IS A LOOSENESS IN THE SCREW THREAD AFTER THE SYRINGE HAS BEEN SCREWED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035503 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.