Alaris, SmartSite 42493ERecalls & reported problems
BD Switzerland Sàrl · Gravity Set, Check Valve 3 Needle-Free Valves, Vented/ Nonvented 264 cm (104 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885403235375), received between Mar 27, 2019 and Apr 7, 2026 — classified as 1 injury, 10 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
- Leak/Splash3
- Break2
- Backflow1
- Component Missing1
- Device Contamination with Chemical or Other Material1
- Failure to Prime1
- Free or Unrestricted Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Consequences Or Impact To Patient3
- Cardiac Arrest1
- Insufficient Information1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 7, 2026Break
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24805407 ↗MalfunctionDec 11, 2025Break; Break
IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT THEY HAD 2 EA BREAK AT THE CONNECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23783962 ↗MalfunctionSep 12, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20200856 ↗MalfunctionJul 7, 2023Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE BD GRAVITY ADMINISTRATION SET WAS OCCLUDED. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: BLOCKED, WHEN SYRINGE IS CONNECTED HE COULD NOT INJECT THE DRUG. MANY UNITS FAILED IN THIS BATCH. NEEDLE-FREE VALVE NOT WORKING MOST ARE BLOCKED, WHEN SYRINGE IS CONNECTED DR CANNOT INJECT DRUG VALVE OPENS AFTER MULTIPLE ATTEMPTS, MAKES A CLICK SOUND THEN SUDDENLY WORKS.
Patient problems: Insufficient Information
MAUDE report 17283491 ↗MalfunctionMay 26, 2022Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET EXPERIENCED OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SOME OF THE IV'S INVOLVED CLOTTED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14516007 ↗MalfunctionMay 26, 2022Backflow; Backflow
IT WAS REPORTED THAT 6 BD ALARIS SMARTSITE GRAVITY SET EXPERIENCED BACKFLOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE HAD 4 PATIENTS TODAY BETWEEN 7 AM AND 1PM USING THE IV TUBING AND BLOOD IS BACKING UP ALL THE WAY UP TO THE BAG WITH FLUIDS IN THE BAG STILL TO BE INFUSED FOR NO REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14515885 ↗MalfunctionMay 25, 2021Component Missing; Free or Unrestricted Flow; Component Missing; Free or Unrestricted Flow
IT WAS REPORTED THAT A GRAV SET 20DP V/NV W/CKV 3SS 104-IN HAD A MISSING ROLLER CLAMP BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THERE'S NO ROLLER CLAMP IT CAME MISSING"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11881108 ↗MalfunctionDec 29, 2020Complete Blockage; Device Contamination with Chemical or Other Material; Complete Blockage; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT GRAV SET 20DP V/NV W/CKV 3SS 104-IN HAD FLOW ISSUES AND FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 42493E, BATCH/ LOT #: 20015396. IT WAS REPORTED THAT THE GRAVITY ADMINISTRATION SET IS NOT DRIPPING ADEQUATELY AND IS DISCOLORED. VERBATIM: WE RECEIVED LOT# AND THE STAFF IS SAYING IT¿S NOT DRIPPING ADEQUATELY. I¿M NOT SURE IF THAT¿S ACTUALLY THE CASE, BUT THE COLOR ON THE TUBE PIECE, NOT THE TUBING IS A DARKER COLOR THAN OTHER LOTS AND THEY ARE CONCERNED THERE¿S AN ISSUE WITH THIS LOT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11088955 ↗MalfunctionDec 3, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 2 GRAV SET 20DP V/NV W/CKV 3SS 104-IN EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT 1: IT WAS REPORTED THAT THE IV TUBING SET WAS INCOMPLETE AND MISSING THE END PIECE. EVENT 2: IT WAS REPORTED THAT THE IV TUBING SET WAS INCOMPLETE AND MISSING THE END PIECE. I WAS ONSITE AT THE USER FACILITY - SAME DAY SURGERY - FOR SOME PIV FOLLOW-UP. WHILE I WAS THERE, A TEAM LEAD APPROACHED ME ABOUT ISSUES WITH THE CAREFUSION IV TUBING THAT THEY USE FOR SURGERY. SHE HAD TWO INCIDENCES OF FAULTY IV TUBING. BOTH SETS WERE INCOMPLETE, WITHOUT THE END PIECE ATTACHED. SHE DOES STILL HAVE THOSE FAULTY SETS AND THE PACKAGES THEY CAME IN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10939004 ↗MalfunctionOct 21, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT GRAV SET 20DP V/NV W/CKV 3SS 104-IN TUBING WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 42493E; BATCH NO: UNKNOWN. IT WAS REPORTED THAT THERE WAS A RECENT ISSUE WITH OUR IV TUBING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10710182 ↗InjuryMar 27, 2019Failure to Prime; Improper Flow or Infusion; No Flow; Failure to Prime; Improper Flow or Infusion; No Flow
IT WAS REPORTED THAT A PATIENT WAS IN CARDIAC ARREST, A PLACEMENT OF AN IO (INTEROSSEOUS) CATHETER WAS INSERTED. THE PARAMEDICS ATTEMPTED TO PRIME THE TUBING HOWEVER FLUID DID NOT PASS EASILY THROUGH THE CHECK VALVE. THE TUBING WAS ABLE TO BE PRIMED AFTER EXTRA PRESSURE APPLIED FROM A PRESSURE BAG BUT UNABLE TO FLOW. A FLUSH WAS PLACED ON THE PORT JUST BELOW THE CHECK VALVE TO TROUBLESHOOT WHERE THE LOCATION OF THE BLOCKAGE AND THE TUBING WAS ABLE TO BE FLUSHED EASILY PAST THE CHECK VALVE HOWEVER WOULD NOT FLOW. THE PARAMEDICS ASSUMED THAT THE IO WAS TO BLAME INITIALLY AND PLACED A SECOND IO WITH ADEQUATE PLACEMENT. WHEN THE USER DID NOT GET ADEQUATE FLOW THROUGH THE PRIMARY TUBING, A SECOND TUBING WAS ATTACHED AND FLOW WAS UNINHIBITED. THERE WAS NO LASTING HARM REPORTED TO THE PATIENT.
Patient problems: Cardiac Arrest
MAUDE report 8456186 ↗
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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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