SOL-M™ Blunt Fill Needle 110021Recalls & reported problems
Sol-Millennium Medical, Inc. · Used in conjunction with a syringe as an additive device for aspiration from multi-dose medicine vials or injection into I.V. systems and pre-slit septums covering injection sites. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818392013900), received between May 16, 2025 and Aug 21, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Defective Component” (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
- Defective Component3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 21, 2025Defective Component; Defective Component
CUSTOMER REPORTED THAT PRIMARY CONTACT HAS HAVE RECEIVED CONCERNS REGARDING SEVERAL INSTANCES OF PIECES OF VIAL STOPPER IN MEDICATION VIALS (ENTYVIO, DAPTOMYCIN) WHEN USING THE SOL-M BLUNT FILL NEEDLE 18G X 1 INCH REF 110021 LOT 05010038 EXPIRY 2025-10-07.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22859817 ↗MalfunctionMay 16, 2025Defective Component; Defective Component
CUSTOMER REPORTED PART OF THE RUBBER WAS ASPIRATED WITH THE MEDICATION WHEN THE NEEDLE WAS USED. THIS IS A SAFETY CONCERN AS THE RUBBER COULD HAVE TRAVELLED IN THE PATIENTS BLOODSTREAM WHEN NOT NOTICED. ALSO THE NEEDLE IS TOO SHORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035702 ↗MalfunctionMay 16, 2025Defective Component; Defective Component
CUSTOMER REPORTED: ACCORDING TO THE HOSPITAL´S NURSES, NOTICING FOR SEVERAL TIMES, HAVE BEEN NOTICING THE FACT THAT WHILE MEDICATION PREPARATION ASPIRATION OF RUBBER PARTICLES WAS OCCURRING. IN FACT, WHEN PENETRATING THE VIAL STOPPER AND ITS POSTERIOR WITHDRAWAL OF THE MEDICATION THEY SAW SOME PARTICLES FLOATING INSIDE THE BARREL OF THE SYRINGE OR IN THE MEDICATION CONTAINER. LOCATION: (B)(6) HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035520 ↗
Other Set, i.V. Fluid transfer devices
- EXACTAMIX H938740Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall1,350 reports
- EXACTAMIX H938738Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall1,180 reports
- EXACTAMIX H938739Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall972 reports
- EXACTAMIX H938741Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall710 reports
- EXACTAMIX H938737Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall607 reports
- EXACTAMIX H938724Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall513 reports
- EXACTAMIX H938173Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls260 reports
- EXACTAMIX H938176Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls232 reports
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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