SOL-CARE™ Luer Lock Safety Syringe with Exchangeable Needle 100077IMRecalls & reported problems
Sol-Millennium Medical, Inc. · Used to inject fluids into, or withdraw fluids from the body. In addition, the device is designed to aid in the prevention of needle stick injuries. · Class 2
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00818392015027), received between May 16, 2025 and Jul 2, 2025 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Defective Component” (4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Component4
- Break2
- Contamination2
- Crack2
- Decoupling2
- Fluid/Blood Leak2
- Retraction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2025Break; Break
THE REPORTED ISSUE IS BARREL BREAKAGE. THE CUSTOMER NOTICED THE BARREL WAS BROKEN AFTER DRAWING UP THE MEDICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22382253 ↗MalfunctionJul 2, 2025Break; Break
CUSTOMER REPORTED THAT THE REAR PART OF THE NEEDLE HUB FRACTURED, RENDERING THE PRODUCT UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22382252 ↗MalfunctionJul 2, 2025Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTED THAT THE MEDICATION LEAKED FROM THE INSIDE OF THE SYRINGE TO THE AREA BEHIND THE RUBBER STOPPER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22382251 ↗MalfunctionJul 2, 2025Crack; Crack
CUSTOMER REPORTED THAT THERE IS A CRACK ON THE SYRINGE, CAUSING LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22382250 ↗MalfunctionJun 19, 2025Contamination; Defective Component; Contamination; Defective Component
CUSTOMER REPORTED THAT THEY AFTER UNPACKING THE MEDICINE, I FOUND YELLOW STAINS INSIDE THE SYRINGE BOTTLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22288940 ↗MalfunctionMay 16, 2025Contamination; Contamination
CUSTOMER COMPLAINT NUMBER: (B)(4). CUSTOMER REPORTED THERE IS A FOREIGN OBJECT INSIDE THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035769 ↗MalfunctionMay 16, 2025Defective Component; Defective Component
CUSTOMER REPORTED THAT AFTER COMPLETING THE INJECTION, WHILE PULLING THE EMPTY SYRINGE BACK INTO THE BARREL WITHOUT APPLYING EXCESSIVE FORCE, THE ENTIRE PLUNGER CAME OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035752 ↗MalfunctionMay 16, 2025Decoupling; Decoupling
CUSTOMER REPORTED THAT THE NEEDLE DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035707 ↗MalfunctionMay 16, 2025Decoupling; Decoupling
CUSTOMER REPORTED: THE NEEDLE FELL OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035668 ↗MalfunctionMay 16, 2025Retraction Problem; Retraction Problem
CUSTOMER REPORTED THAT THE NEEDLE SUDDENLY RETRACTED AUTOMATICALLY IN MID-USE. THIS ISSUE HAS OCCURRED MULTIPLE TIMES, RAISING CONCERNS ABOUT QUALITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035655 ↗MalfunctionMay 16, 2025Defective Component; Defective Component
CUSTOMER REPORTED A PART OF THE SYRINGE'S PLASTIC PIECE IS STUCK TO THE BLACK STOPPER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035649 ↗MalfunctionMay 16, 2025Defective Component; Defective Component
CUSTOMER REPORTED: VACCINE BOTTLES ARE LEAKING AND CUSTOMER IS HAVING RE-CAP ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035648 ↗MalfunctionMay 16, 2025Crack; Crack
"(B)(4) - CUSTOMER REPORTED THAT THE EMPTY NEEDLE HAS A CRACK AND CANNOT BE USED. (B)(4) - CUSTOMER REPORTED THAT THE SYRINGE BARREL IS CRACKED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035492 ↗MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTED THAT WHEN THE VACCINE IS ADMINISTERED IN THE OUTPATIENT CLINIC, LEAKAGE BEGINS TO LEAK NEAR THE NEEDLE, RESULTING IN A SHORTAGE OF MEDICINE AND A NEW BOTTLE OF MEDICINE IS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035444 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.