SOL-M™ Holder with Male Luer Lock Adapter 110201050003Recalls & reported problems
Sol-Millennium Medical, Inc. · SOL-M™ Tube Holder with Luer Lock Adapter · 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 00818392018158), received between Jun 22, 2022 and Mar 18, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Fluid/Blood Leak1
- Inability to Auto-Fill1
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.
MalfunctionMar 18, 2026Break
CUSTOMER REPORTED THAT THE LUER-LOCK CONNECTOR BROKE INVOLVING AN IMPORTANT BLOOD LEAKAGE ON THE FLOOR IN ICU.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24634539 ↗MalfunctionJan 7, 2026Fluid/Blood Leak
CUSTOMER REPORTED THAT THE BLOOD RETURN IS INCONSISTENT AND OCCASIONALLY HAS BLOOD LEAKAGE WHEN CONNECTED TO THE BLUE HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23988086 ↗MalfunctionJun 22, 2022Inability to Auto-Fill
CUSTOMER REPORTED THAT WHEN ATTACHING THIS PRODUCT TO THE NEEDLESS ADAPTER TIGHTLY AND THE VACUTAINER TUBE INSERTED, THERE IS NO SUCTION. THEY TRIED TO USE IT MULTIPLE TIMES DURING BLOOD WORK. SHE SAID THAT IT OCCURED WITH ROUGHLY 10 PATIENTS, NO SPECIFIC PROVIDED. THIS WAS THE FIRST TIME USING THE ADAPTER. NO HARM TO ANY PATIENT HOWEVER, THERE WAS A DELAY IN TREATMENT. POSSIBLE LOFF OF IU SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14778313 ↗
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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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