SOL-M 10ml Luer Lock Syringe Sterile Convenience Tray P180010TURecalls & reported problems
Sol-Millennium Medical, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00810062434305), received between May 16, 2025 and Jun 19, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Contamination” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Contamination3
- Crack1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 19, 2026Contamination
CUSTOMER REPORTED THAT DURING THE 100% VISUAL INSPECTION PROCESS, SEVERAL UNITS WERE REJECTED FOR "PARTICULATE/MATERIAL IN THE OTHER CATEGORY, SUSPENDED IN SOLUTION OR ADHERED TO INTERNAL SURFACE OF CONTAINER". THIS IMPACTED FOUR COMPOUNDED LOTS. THE PARTICULATE(S) WERE ANALYZED BY THE QC LAB AND DETERMINED TO BE A POLYESTER FIBER/NATURAL FIBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25561754 ↗MalfunctionMay 5, 2026Contamination
CUSTOMER REPORTED THAT THE FOREIGN MATERIAL FOUND IN SYRINGE TRAYS. CONTAMINATION IDENTIFICATION ANALYSIS PROVIDED BY THE CUSTOMER INDICATED THAT THE OBSERVED FOREIGN MATERIAL CONSISTED OF: · FIBROUS PARTICLES CONSISTENT WITH POLYESTER FIBERS. · LUBRICANT-TYPE PARTICLES CONSISTENT WITH SILICONE-BASED MATERIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25089793 ↗MalfunctionMay 16, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
CUSTOMER REPORTED THE SYRINGES EXPERIENCED CRACKING DURING USE, WHICH LED TO PRODUCT LEAKAGE AND A LOSS OF PRIMARY PACKAGE INTEGRITY. PRODUCT USED WITH ROPIVACAINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035724 ↗MalfunctionMay 16, 2025Contamination; Contamination
CUSTOMER REPORTED: WE OBSERVED RUST-LIKE PARTICLES IN ONE OF THE 10ML SYRINGES FROM LOT# 04301002. PLEASE FIND THE ATTACHED IMAGE AND A SMALL VIDEO. PLEASE LET US KNOW THE WAY FORWARD TO ADDRESS THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035642 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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