SOL-M 20ml Luer Lock Syringe w/o Needle (bulk ,sterile) P180020BSRecalls & reported problems
Sol-Millennium Medical, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00810018095185), received between May 16, 2025 and Jul 2, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
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.
MalfunctionJul 2, 2025Break; Break
CUSTOMER REPORTED FOLLOWING TWO COMPLAINTS, CUSTOMER DESCRIPTION: (B)(4). THE PROBLEM WAS THAT ONE OF THE 20 ML SYRINGES WAS BROKEN AT THE TIP. WE COULDN'T FIND THE TIP ANYWHERE, BUT THERE IS CONCERN ABOUT WHETHER THERE MIGHT BE A LOOSE PIECE TO WATCH OUT FOR DURING THE SURGERY. NO HARM REPORTED. CUSTOMER DESCRIPTION: (B)(4). A 20 ML SYRINGE TIP THAT SNAPPED OFF IN HUB OF DRUG ELUTING STENT WHEN PREPPING ( DE-AIRING) THE STENT FOR DELIVERY. THIS LEFT THE STENT UNUSABLE, SO A NEW SYRINGE AND STENT WERE OPENED. THESE WERE THEN USED TO COMPLETE STENTING. THIS IS A MASSIVE EXPENSE TO THE CUSTOMER. NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22382249 ↗MalfunctionMay 16, 2025Break; Break
CUSTOMER REPORTED: A 20 ML SYRINGE TIP THAT WAS WITHIN THE CUSTOM PACK SNAPPED OFF IN HUB OF DRUG ELUTING STENT WHEN PREPPING (DE-AIRING) THE STENT FOR DELIVERY. THIS LEFT THE STENT UNUSABLE, SO A NEW SYRINGE AND STENT WERE OPENED. THESE WERE THEN USED TO COMPLETE STENTING. TYPE OF SURGERY: ANGIOGRAPHY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035737 ↗
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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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