SOL-CARE Safety Multi-Sample Needle with Pre-attached Holder SMSNH21125Recalls & reported problems
Sol-Millennium Medical, Inc. · SOL-CARE Safety Multi-Sample Needle with Pre-attached Holder 21G*1 1/4 · 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 00818392014952), received between May 16, 2025 and Sep 15, 2026 — 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
- Loose or Intermittent Connection1
Patient problems
- Device Embedded In Tissue or Plaque1
- 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.
MalfunctionSep 15, 2026Loose or Intermittent Connection
Customer reported a needle was pulled along entirely when changing a tube.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50766986 ↗MalfunctionMay 16, 2025Defective Component; Defective Component
CUSTOMER REPORTED THE VACUUM BECAME LOOSE WHEN THE TUBE IS INSERTED AND WHEN WE TRIED TO REMOVE THE NEEDLE, THE NEEDLE REMAINS IN THE VEIN. THIS HAPPENED ONLY ONCE BUT IT IS QUITE DANGEROUS IF THE NEEDLE REMAINS INSIDE THE SUBJECT VEIN.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22035659 ↗
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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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