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Alaris, SmartSite 0.00425Recalls & reported problems

BD Switzerland Sàrl · Gravity Set, Check Valve, 3 Needle-Free Valves, 3 Port Manifold, Vented/Nonvented, 335 cm (132 in) · Class 2

All models of Alaris, SmartSite (160)

Data updated Oct 18, 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 10885403240294), received between Oct 12, 2021 and May 1, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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

  • Leak/Splash2
  • Backflow1
  • Complete Blockage1
  • Separation Problem1

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.

  • MalfunctionMay 1, 2023Separation Problem; Separation Problem

    IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SET CHAMBER DISLODGED FROM THE TUBING WHEN REMOVING IT FROM THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "GRAVITY TUBE ISSUE ON (B)(6) 2023 OPENED PACKAGING FOR A GRAVITY SET AND THE CHAMBER DISLODGED FROM THE TUBING... NOT USED ON PATIENT NO DELAY IN CARE"

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16850306 ↗
  • MalfunctionOct 12, 2021Backflow; Complete Blockage; Leak/Splash; Backflow; Complete Blockage; Leak/Splash

    IT WAS REPORTED THAT THE GRA 15DP 3PSSMNFLD 3SS CV DEHP FREE TUBING SEPARATED AND LEAKED IV FLUID ONTO THE FLOOR, AND THE PATIENT'S BLOOD BACKED UP INTO THE OPEN-ENDED IV TUBING. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I THINK WE NEED TO BE CLEAR THAT THIS PROBLEM DOES NOT STEM FROM A USER ERROR. THIS SAME ISSUE HAS OCCURRED TO ME IN MORE THAN ONE CASE, THE MOST RECENT OVER LAST WEEKEND. I INJECTED A MEDICATION INTO ONE OF THE PORTS ON THE MULTI-PORT HUB... I TURNED AROUND TO CHART THE MEDICATION. I TURNED BACK AROUND TOWARDS THE PATIENT TO FIND IV FLUID DUMPING ONTO THE FLOOR AND THE PATIENT¿S BLOOD BACKING UP INTO THE FREE HANGING OPEN ENDED IV TUBING. AGAIN, THIS HAS HAPPENED TO ME MORE THAN ONCE. IT HAS HAPPENED IN THE DEPARTMENT MULTIPLE TIMES. THIS HAS NOT BEEN AN ONGOING ISSUE, SO SOMETHING MUST HAVE CHANGED."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12615928 ↗
  • MalfunctionOct 12, 2021Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT THE GRA 15DP 3PSSMNFLD 3SS CV DEHP FREE IV TUBING SEPARATED DUE TO ONE END NOT BEING THREADED OR TIGHTENED. THIS OCCURRED WITH 2 SETS DURING USE, AND THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DR. XXXX WAS ABLE TO SHOW ME ANOTHER IV TUBING SET THAT CAME APART. LOOKS LIKE THE ONE END OF TUBING IS NOT THREADED AND IF NOT TIGHTENED, THE TUBING WOULD EASILY COME APART... ON THE LEFT SIDE, BOTH ENDS OF THE CONNECTION ARE THREADED."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12615926 ↗

Other Set, administration, intravascular devices

All Set, administration, intravascular devices →

Sources and updates

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