FLUID SYSTEMS ACCESSORIES 2N3364Recalls & reported problems
Baxter Healthcare Corporation · Anti-Siphon Valve · Class 2
Data updated Oct 16, 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 00085412639413), received between Feb 18, 2025 and Jan 13, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak2
- Break1
- Incomplete or Inadequate Connection1
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.
MalfunctionJan 13, 2026Incomplete or Inadequate Connection
IT WAS REPORTED THAT THE LUER LOCK OF AN ANTI-SIPHON VALVE WOULD NOT THREAD ONTO A NS (NORMAL SALINE) SYRINGE FOR A BIFUSE. THIS WAS OBSERVED WHILE PREPARING TPN (TOTAL PARENTERAL NUTRITION). THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24060877 ↗MalfunctionAug 29, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
IT WAS REPORTED THAT AN ANTI-SIPHON VALVE LEAKED FROM AN UNSPECIFIED LOCATION. THERE WERE TWO SMALL CRACKS IN THE VALVE. THIS WAS OBSERVED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22922678 ↗MalfunctionFeb 18, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN ANTI-SIPHON VALVE WAS LEAKING BETWEEN THE FEMALE SITE OF THE PRODUCT AND THE MALE SITE OF THE "IL" FILTER DESPITE BEING PROPERLY CONFIGURED AND FULLY SCREWED INTO PLACE ON THE LINE SETUP. THIS OCCURRED DURING USE. TO RESOLVE THIS ISSUE, THE LINE WAS TAKEN DOWN AND REPLACED WITH A NEW LINE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21404114 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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