SOL-CARE™ Safety Blood Collection Needle 110201030031Recalls & reported problems
Sol-Millennium Medical, Inc. · SOL-CARE™ Safety Blood Collection Needle 21G*3/4*12inch (US) · 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 00818392017267), received between May 16, 2025 and May 16, 2025 — classified as 2 malfunctions.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Component1
- Fluid/Blood Leak1
Patient problems
- Needle Stick/Puncture1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 16, 2025Defective Component; Defective Component
THE CUSTOMER REPORTED THAT THE PCA WAS ATTEMPTING VENI PUNCTURE BLOOD DRAW TO PATIENTS LEFT AC. AFTER RETRACTING NEEDLE INTO SAFETY PLASTIC TIPS, PLASTIC TIP PINCHED PATIENTS ARM AT INSERTION SITE. PLASTIC PIECE PINCHED PATIENT'S ARM. AFTER RETRACTING NEEDLE, THE PLASTIC PIECE WAS STUCK TO PATIENTS' ARM.
Patient problems: Needle Stick/Puncture
MAUDE report 22035768 ↗MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTED THAT THEY HAVING ISSUES BLOOD LEAKING WHERE THE GRAY HUB END IS DURING A VENIPUNCTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035756 ↗
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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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