Alaris, SmartSite 42434ERecalls & reported problems
BD Switzerland Sàrl · Gravity Set, Check Valve 3 Needle-Free Valves, 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
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885403235368), received between Mar 17, 2022 and Jul 29, 2025 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Material Separation” (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
- Material Separation3
- Defective Component1
- Device Damaged Prior to Use1
- Infusion or Flow Problem1
- Leak/Splash1
- Misassembled1
- Obstruction of Flow1
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 29, 2025Misassembled; Obstruction of Flow; Misassembled; Obstruction of Flow
IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT IT UNABLE TO DRIP/FLOW THROUGH THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22661085 ↗MalfunctionNov 20, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM ED AND OR DEPARTMENT LEADERSHIP STATED THE NURSING STAFF HAVE COMPLAINED ABOUT THE BD SMART SITE GRAVITY SET 42434E. LEADERSHIP AND NURSING STAFF HAVE STATED THE SET RUNS VERY SLOW TO GRAVITY. STATES THAT THE BD DEDICATED PRIMARY SET RUNS MUCH FASTER TO GRAVITY THEN THE ACTUAL GRAVITY SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20737822 ↗MalfunctionFeb 10, 2023Material Separation; Material Separation
IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SET TUBING WAS DEFECTIVE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE WAS A SECOND TUBE THAT FAILED THE NEXT DAY IN THE SAME MANNER...WHAT THE ISSUE WAS WITH THE PRODUCT? UNKNOWN, TUBING FELL APART".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16357562 ↗MalfunctionFeb 9, 2023Defective Component; Defective Component
IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SET TUBING WAS DEFECTIVE/DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "COMPLAINT WE RECEIVED FROM OUR RADIOLOGY DEPARTMENT. I AM WORKING ON GETTING SOME MORE INFORMATION ON WHAT HAPPENED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16331534 ↗MalfunctionMar 20, 2022Material Separation; Material Separation
IT WAS REPORTED THAT 2 BD GRAVITY SET 60DP 3SS DEHP FREE SETS HAD COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE USER REPORTED THAT THE IV TUBING THAT CONNECTS INTO THE SPIKE POPPED OFF AND IT LOOKS LIKE IT HAS BEEN CLIPPED. THIS IS THE 2ND OF THE MICRODRIP IV TUBING TO DO THIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13829676 ↗MalfunctionMar 20, 2022Material Separation; Material Separation
IT WAS REPORTED THAT 1 BD ALARIS¿ SMARTSITE¿ GRAVITY SET HAD COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE USER REPORTED TUBING DISLODGED FROM THE DRIP CHAMBER AND THE SAME THING HAPPENED ABOUT 1 MONTH AGO IN THE OR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13829485 ↗MalfunctionMar 20, 2022Device Damaged Prior to Use; Device Damaged Prior to Use
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING BROKEN IN PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13828330 ↗MalfunctionMar 17, 2022Leak/Splash; Separation Problem; Leak/Splash; Separation Problem
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET EXPERIENCED COMPONENT SEPARATION, AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN WAS PRIMING IV FLUIDS WHEN THE TUBE FELL OFF OF THE DRIP CHAMBER. IVF WENT EVERYWHERE. THANKFULLY NO HARM WAS DONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13800926 ↗
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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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