Alaris, SmartSite 41134ERecalls & 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
- 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 10885403235283), received between Jun 28, 2021 and Jun 5, 2023 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (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 18, 2026.
Most reported problems
Device problems
- Complete Blockage2
- Backflow1
- Component Missing1
- Contamination of Device Ingredient or Reagent1
- Device Contamination with Chemical or Other Material1
- Leak/Splash1
- Material Separation1
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.
MalfunctionJun 5, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SETS' TUBING WAS DISCOLORED TO BROWN. THIS OCCURRED WITH 6 SETS IN LOT 20109509, 4 IN LOT 22089339, 2 IN LOT 22069069, 3 IN LOT 22069195, 2 IN LOT 22089388, AND 1 EACH IN LOTS 22039029, 20099511, 21129105, AND AN UNSPECIFIED LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBING HAS TURNED A BROWN COLOUR".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17060571 ↗MalfunctionDec 7, 2022Material Separation; Material Separation
IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SET CAME APART. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: END PIECE NOT CONNECTED TO TUBING AND CAME APART WHILE PREPARING TO CONNECT TO IV FLUIDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15936399 ↗MalfunctionOct 27, 2022Component Missing; Component Missing
IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SET WAS MISSING SOME OF ITS COMPONENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE LAWSON 116203, SET IV GRAVITY 10DP 41134E , THAT WAS MISSING SOME PIECES."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15682392 ↗MalfunctionJul 29, 2022Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent
IT WAS REPORTED THAT THE BD GRAVITY ADMINISTRATION SET EXPERIENCED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF OUR PRE-OP NURSES NOTICED A LUBRICANT AROUND THE SPIKE ON LAWSON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15131537 ↗MalfunctionAug 9, 2021Backflow; Complete Blockage; Backflow; Complete Blockage
IT WAS REPORTED THAT THE GRAVITY SET V/NV CKV 3SS 10DP TUBING ALLOWED BLOOD TO BACKFLOW THROUGH THE ACCESS PORT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON FRIDAY, JULY 9, I RECEIVED A CALL FROM (B)(6) ABOUT IV TUBING THAT HAD ALLOWED BLOOD TO BACK UP AND COME OUT OF ONE OF THE ACCESS PORTS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12294682 ↗MalfunctionJul 21, 2021Complete Blockage; Complete Blockage
IT WAS REPORTED THAT 2 GRAVITY SET V/NV CKV 3SS 10DP EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I SPIKED A 1000 ML LR AND THE FLUID WOULD ONLY FILL THE DRIP CHAMBER. IT WOULD NOT PRIME THE LINE. I HAD THIS SAME THING HAPPEN LAST WEEK BUT THE DRIP CHAMBER FILLED AND THE TUBING PRIMED BUT IT WOULD NOT RUN AFTER THAT AND CAUSED US TO START A SECOND IV SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12207603 ↗MalfunctionJun 28, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 2 GRAVITY SET V/NV CKV 3SS 10DP EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 41134E, BATCH/LOT #: 21039516. THERE HAS BEEN TWO SEPARATE INSTANCES WHERE TUBING 41134E HAS LEAKED IN SURGERY PRE OP. AFTER THE SECOND ONE, I TRADED OUT TUBING FROM CENTRAL. I KEPT THE TUBING WITH LOT# (10)21039516, ALONG WITH THE TWO THAT HAD LEAKED. THE LEAKAGE EACH TIME WAS AT A DIFFERENT CHECK VALVE/INJECTION SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12081099 ↗
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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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