SOL-CARE™ Insulin Safety Syringe with Fixed Needle 100017IMRecalls & reported problems
Sol-Millennium Medical, Inc. · Used to inject insulin into the body. In addition, the device is designed to aid in the prevention of needle stick injuries. · 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 00818392014907), received between Jun 6, 2023 and Nov 21, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Skin Tears1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 21, 2025Leak/Splash; Leak/Splash
CUSTOMER REPORTED SYRINGES WITH LEAKAGE. THE LEAKAGE APPEARS IN THE SYRINGE TIP, BETWEEN THE INNER PART WHERE THE LIQUID IS DRAWN AND THE OUTER SECTION OF THE SYRINGE. CUSTOMER DESCRIPTION OF QUALITY ISSUE: WE FILLED NINE SYRINGES WITH HYDROXOCOBALAMIN 5 MG/ML, REMOVED THE AIR, AND ADJUSTED THE VOLUME TO 0.6 ML. THE SYRINGES WERE THEN PACKED IN INDIVIDUAL BAGS. APPROXIMATELY 20 MINUTES LATER, DURING A ROUTINE CHECK, LEAKAGE WAS DISCOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23616551 ↗MalfunctionJun 6, 2023Fracture; Fracture
THE CUSTOMER REPORTED THE NURSE WAS GOING TO ADMINISTER INSULIN TO THE PATIENT IN THE ABDOMEN AND AFTER ADMINISTERING, REMOVED THE SYRINGE AND DID NOT SEE THE NEEDLE. NEEDLE BROKE AND STAYED INSIDE THE PATIENT. EXISTENCE OF NEEDLE WAS CONFIRMED BY XRAY. NO ADDITIONAL INFORMATION PROVIDED
Patient problems: Skin Tears
MAUDE report 17074696 ↗
Other SYRINGE, ANTISTICK devices
- BD Integra 305270Becton, Dickinson And Company · SYRINGE, ANTISTICK261 reports
- BD Integra 305271Becton, Dickinson And Company · SYRINGE, ANTISTICK106 reports
- BD Integra 305269Becton, Dickinson And Company · SYRINGE, ANTISTICK85 reports
- BD Luer-Lok, BD SafetyGlide 305924Becton, Dickinson And Company · SYRINGE, ANTISTICK1 recall28 reports
- BD Integra 305272Becton, Dickinson And Company · SYRINGE, ANTISTICK71 reports
- BD SafetyGlide 305945Becton, Dickinson And Company · SYRINGE, ANTISTICK63 reports
- BD SafetyGlide 305950Becton, Dickinson And Company · SYRINGE, ANTISTICK61 reports
- Medline SYRS101235FMedline Industries, Inc. · SYRINGE, ANTISTICK1 recall0 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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