Alaris, SmartSite 30263ERecalls & reported problems
BD Switzerland Sàrl · Extension Set, 2 Needle-Free Valves 102 cm (40 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 10885403235207), received between Jul 19, 2021 and Apr 12, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Backflow” (1 report).
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
- Backflow1
- Infusion or Flow Problem1
- Material Separation1
- Misassembled1
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.
MalfunctionApr 12, 2023Material Separation; Material Separation
IT WAS REPORTED WHILE USING BD ALARIS SMARTSITE EXTENSION SET THERE WAS COMPONENT SEPARATION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ADDITIONAL SAMPLES WERE RECEIVED FROM THE CUSTOMER WITH THE BELOW DEFECT. 30263E - QTY 1 LOT 22059434- IN SAMPLE 1 THE ISSUE OF SEPARATION OBSERVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16725684 ↗MalfunctionAug 9, 2021Backflow; Infusion or Flow Problem; Backflow; Infusion or Flow Problem
IT WAS REPORTED 40 INCH EXT W/2 VLV PORTS ALLOWED BACKFLOW OF BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON FRIDAY, JULY 9, I RECEIVED A CALL FROM ANESTHSIA 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 12294186 ↗MalfunctionJul 19, 2021Misassembled; Misassembled
IT WAS REPORTED THAT AT LEAST ONE 40 INCH EXT W/2 VLV PORT EXPERIENCED A MISSING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CALLER STATES PART NUMBER 20028E USED TO HAVE A SWIVEL ON ONE SIDE AND NO LONGER HAS A SWIVEL. CALLER WANTS TO KNOW IF THERE HAS BEEN A CHANGE TO THE PRODUCT. CALLER STATES PRODUCT 30263E HAS A SIMILAR CONSTRUCT. CALLER STATES THEY HAVE MANY OF THESE PRODUCTS AND HAD THIS ISSUE A FEW MONTHS AGO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12191711 ↗
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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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