Alaris, SmartSite 42290ERecalls & reported problems
BD Switzerland Sàrl · Gravity Set Check Valve 2 Needle-Free Valves Nonvented · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613203010931), received between Jul 30, 2021 and Nov 22, 2024 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (3 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
- Complete Blockage3
- Device Contamination with Chemical or Other Material1
- Free or Unrestricted Flow1
- Leak/Splash1
- Material Separation1
- Restricted Flow rate1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 22, 2024Free or Unrestricted Flow; Free or Unrestricted Flow
IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET HAD AIR IN LINE. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: THERE IS AN AIR BUBBLE IN THE TUBING WHEN THE FLUID IS CONNECTED, AND ANAESTHETIC TECH NEEDS TO USE A SYRINGE TO RID THE AIR OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20759625 ↗MalfunctionAug 8, 2023Material Separation; Material Separation
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17484266 ↗MalfunctionApr 10, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET EXPERIENCED FOREIGN MATTER, CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A LARGE MOBILE FOREIGN BODY (APPEARS TO BE A PIECE OF METAL) WAS DISCOVERED IN A IV GIVING SET PRIOR TO PATIENT USE BUT AFTER IT HAD BEEN RUN THROUGH. LINE HAS FLUID IN IT BUT HAS NOT BEEN USED ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16708712 ↗MalfunctionMay 5, 2022Complete Blockage; Complete Blockage
IT WAS REPORTED 2 BD ALARIS SMARTSITE GRAVITY SETS HAD BLOCKAGE ISSUES DURING PRIMING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SETS WERE OBSERVED TO NOT BE FLOWING DURING PRIMING".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14286043 ↗MalfunctionApr 19, 2022Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY WERE DOUBLE CHECKING THE VALVES IN THE GIVING SET AND FOUND ONE OF THE VALVES IS BACK TO FRONT HENCE THERE IS NO FREE FLOW OF INFUSION FLUID.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14146668 ↗MalfunctionAug 19, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate
IT WAS REPORTED THAT THE GRAVITY SET W/CV 2SS 20 DP UNV WAS DIFFICULT TO INJECT THROUGH DUE TO FLOW ISSUES/BLOCKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE HAVE BEEN SEVERAL ISSUES, IN THEATRE, WHERE SPECIALISTS HAVE BEEN UNABLE TO INJECT THROUGH THE BD SMART SITE CONNECTOR (2000E-04) AND BD SMART SITE GRAVITY SET (42209E). THIS HAS BEEN PREDOMINANTLY WITH THE PREFILLED JUNO SYRINGES CONTAINING EPHEDRINE AND METARAMINOL BUT HAS ALSO OCCURRED WITH BD PLASTIPAK LUER LOK TIP SYRINGES OF ALL SIZES. IT SEEMS THAT THE ISSUES RELATE ONLY TO THE BUNGS AT PRESENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12344659 ↗MalfunctionJul 30, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT GRAVITY SET W/CV 2SS 20 DP UNV WAS DIFFICULT TO CONNECT AND OFTEN DISCONNECTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN CONNECTING TO THE SMARTSITE IT IS DIFFICULT TO CONNECT AND TAKES SEVERAL ATTEMPTS, OFTEN DISCONNECTING TO FLUSH THE AND 'BREAK THE SEAL' BEFORE RECONNECTING. ISSUE IS INTERMITTENT NOT HAPPENING ALL THE TIME. WHEN CONNECTING THEY ARE DOING AND EXTRA HARD SCREW TO ENSURE THAT THE BLUE CONCERTINA DEPRESSES AND DOES NOT RESIST. THEY FEEL THE ISSUE MAYBE WITH THE BLUE PART OF THE COMPONENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12253221 ↗
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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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