SOL-CARE™ Luer Lock Safety Syringe with Exchangeable Needle 160072IMRecalls & 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. 10ml 21g x 1 1/2" exchangeable needle · Class 2
All models of SOL-CARE Luer Lock Safety Syringe with Exchangeable Needle (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00818392015041), received between May 16, 2025 and Mar 24, 2026 — classified as 18 malfunctions.
The most frequently reported specific device problem is “Decoupling” (5 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
- Decoupling5
- Fluid/Blood Leak3
- Retraction Problem3
- Break2
- Contamination2
- Crack1
- Defective Component1
- Difficult to Fold, Unfold or Collapse1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- Needle Stick/Puncture2
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 24, 2026Break
CUSTOMER REPORTED THE SYRINGE WAS CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24673966 ↗MalfunctionFeb 17, 2026Break
CUSTOMER REPORTED A CRACK WAS FOUND IN THE SYRINGE BARREL DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24362469 ↗MalfunctionDec 2, 2025Contamination; Contamination
CUSTOMER REPORTED COTTON FIBERS WERE FOUND INSIDE THE SYRINGE, MAKING IT UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23692121 ↗MalfunctionDec 1, 2025Leak/Splash; Premature Activation; Leak/Splash; Premature Activation
CUSTOMER REPORTED DURING BLOOD COLLECTION, THE NEEDLE SUDDENLY RETRACTED, CAUSING BLOOD LEAKAGE. CUSTOMER REPORTED THE NEEDLE DETACHED, CAUSING LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23679891 ↗MalfunctionJun 20, 2025Crack; Crack
CUSTOMER REPORTED THAT AFTER USING THE EMPTY SYRINGE FOR BLOOD COLLECTION, IRREGULAR CRACKSWERE FOUND ON THE OUTER BARREL OF THE SYRINGE, INDICATING A NEED TO ENHANCE QUALITY CONTROL. CUSTOMER REPORTED THAT THE SYRINGE BARREL IS CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22294681 ↗MalfunctionJun 20, 2025Contamination; Defective Component; Contamination; Defective Component
CUSTOMER REPORTED THAT THEY WHEN OPENING THE NEEDLE FOR USE, IT WAS FOUND THAT THERE WAS FOREIGN MATTER (PLASTIC BLOCK) INSIDE THE EMPTY NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22294680 ↗MalfunctionJun 11, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse
CUSTOMER COMPLAINT NO. (B)(4). CUSTOMER REPORTED THAT WHILE USING THE SYRINGE TO DRAW MEDICATION, IT SUDDENLY BECAME IMPOSSIBLE TO PUSH FORWARD OR PULL BACK. THE SAME ISSUE OCCURRED CONSECUTIVELY WITH TWO 10CC SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22182343 ↗MalfunctionJun 11, 2025Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER COMPLAINT NO. (B)(4). CUSTOMER REPORTED THAT WHEN DRAWING MEDICINE WITH AN EMPTY NEEDLE, THE MEDICINE FLOWSBACKWARD. CUSTOMER COMPLAINT NO: (B)(4). CUSTOMER REPORTED THAT AFTER DRAWING THE MEDICATION, LEAKAGE OCCURS FROM THE BLACK RUBBERSTOPPER DURING INJECTION. CUSTOMER COMPLAINT NO: (B)(4). CUSTOMER REPORTED THAT WHEN DRAWING THE MEDICATION, IT LEAKS FROM THE NEEDLE HUB. CUSTOMER COMPLAINT NO: (B)(4). CUSTOMER REPORTED THAT THE SYRINGE MALFUNCTIONED, WITH LEAKAGE OCCURRING FROM THE BACK OF THERUBBER STOPPER. CUSTOMER COMPLAINT NO: (B)(4). CUSTOMER REPORTED THAT THE BACK END OF THE SYRINGE IS LEAKING. CUSTOMER COMPLAINT NO: (B)(4). CUSTOMER REPORTED THAT THE MEDICATION LEAKS OUT FROM THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22182335 ↗MalfunctionMay 29, 2025Retraction Problem; Retraction Problem
"CUSTOMER COMPLAINT NO: (B)(4). CUSTOMER REPORTED THAT THE NEEDLE RETRACTED AUTOMATICALLY, CAUSING A NEEDLESTICK INJURY TO A HOSPITAL NURSE. ADDITIONALLY, THE COMPLAINT FREQUENCY FOR THIS BATCH IS EXCESSIVELY HIGH, AND A FULL BATCH REPLACEMENT IS REQUIRED. CUSTOMER COMPLAINT NO: (B)(4). CUSTOMER REPORTED THAT WHEN FIRST OPENED AND USED, THE NEEDLE SUDDENLY RETRACTED, CAUSING THE NURSING STAFF TO ALMOST EXPERIENCE A NEEDLESTICK INJURY. "
Patient problems: Needle Stick/Puncture
MAUDE report 22106380 ↗MalfunctionMay 22, 2025Decoupling; Decoupling
CUSTOMER REPORTED THAT THE NEEDLE SUDDENLY DETACHED DURING THE MEDICATION EXTRACTION PROCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22073541 ↗MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTED WHEN USING A 10ML SAFETY INJECTION NEEDLE TO DRAW MEDICATION, LEAKAGE OCCURRED AT THE CONNECTION BETWEEN THE NEEDLE AND THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035747 ↗MalfunctionMay 16, 2025Decoupling; Decoupling
CUSTOMER REPORTED THAT THE NEEDLE DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035734 ↗MalfunctionMay 16, 2025Decoupling; Decoupling
CUSTOMER REPORTED THAT THE NEEDLE DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035731 ↗MalfunctionMay 16, 2025Retraction Problem; Retraction Problem
CUSTOMER REPORTED THAT THE WHILE USING A 10ML SAFETY SYRINGE TO DRAW MEDICATION, THE NEEDLE HUB SUDDENLY RETRACTED AND DETACHED, CAUSING CONTAMINATION OF THE MEDICATION, MAKING IT UNUSABLE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035728 ↗MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTED THAT THE AFTER DRAWING THE MEDICATION, THE NEEDLE DETACHED DURING ADMINISTRATION, CAUSING MEDICATION SPILLAGE. THE MANUFACTURER MUST COMPENSATE (B)(6) FOR THE MEDICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035719 ↗MalfunctionMay 16, 2025Decoupling; Decoupling
CUSTOMER REPORTED THAT DURING THE MEDICATION EXTRACTION PROCESS, THE NEEDLE AUTOMATICALLY DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035672 ↗MalfunctionMay 16, 2025Decoupling; Decoupling
CUSTOMER REPORTED THAT THE FRONT END OF THE SYRINGE BECAME LOOSE, MAKING IT IMPOSSIBLE TO DRAW MEDICATION AND CAUSING A NEEDLESTICK INJURY TO THE NURSING STAFF
Patient problems: Needle Stick/Puncture
MAUDE report 22035666 ↗MalfunctionMay 16, 2025Retraction Problem; Retraction Problem
CUSTOMER REPORTED UPON OPENING THE PACKAGING, IT WAS FOUND THAT THE NEEDLE HAD ALREADY RETRACTED AND WAS UNUSABLE. THIS ISSUE HAS OCCURRED MULTIPLE TIMES AND REQUIRES ENHANCED QUALITY CONTROL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035646 ↗
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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