SOL-CARE™ Safety Needle SN2115Recalls & reported problems
Sol-Millennium Medical, Inc. · The SOL-CARE™ Safety Needle is used for general purpose injection and aspiration of fluids from vials, ampules, and parts of the body below the surface of the skin. · Class 2
- 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 00818392010589), received between May 16, 2025 and May 16, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
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, 2025Break; Break
CUSTOMER REPORTED: THE ISSUE THEY HAVE HAD IS THAT THE NEEDLE REFERENCE (B)(6) BROKE WHILE BEING USED INSIDE THE PATIENT. WE ARE CHECKING WITH THE CUSTOMER IF THEY HAVE RAISED AN MHRA COMPLAINT. OBVIOUSLY THIS IS A CONCERNING ISSUE, AND FOR THE MOMENT, THE CUSTOMER HAS QUARANTINED THE PACKS WITH THIS REFERENCE, BUT OBVIOUSLY WE NEED TO KNOW THE LOT NUMBER OF THE NEEDLE AS THERE MAY BE OTHER LOTS OF PACKS AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035824 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.