Alaris, SmartSite 20511ERecalls & reported problems
BD Switzerland Sàrl · Combination Extension Set, 4-Way Stopcock, 2 One-Way Valves, Extension Set with Needle-Free Valve 114cm (45 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885403234934), received between Sep 16, 2021 and Apr 27, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash3
- Complete Blockage2
- Restricted Flow rate2
- Defective Component1
- Disconnection1
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 27, 2026Disconnection; Leak/Splash; Separation Problem
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT WHILE CONNECTED TO A PATIENT IN THE OR UNDER ANESTHESIA, THERE WAS A DISCONNECT FROM JUST PRIOR TO THE MOST DISTAL CONNECTION REPORT ON THE MANIFOLD AND BLOOD POURED FROM THE PATIENT OUT OF THE LINE DOWN TO THE FLOOR WHILE IV FLUIDS POURED FROM THE OTHER SIDE ONTO THE FLOOR. THERE WAS NO UNDUE PRESSURE ON THIS IV LINE, IT WAS HANGING DOWN BY GRAVITY AT THE END OF THE BED AND LOOPING UP TO THE IV BAG ON A POLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25007980 ↗MalfunctionNov 7, 2023Leak/Splash; Defective Component; Leak/Splash; Defective Component
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18089359 ↗MalfunctionSep 16, 2021Complete Blockage; Restricted Flow rate; Leak/Splash; Complete Blockage; Restricted Flow rate; Leak/Splash
IT WAS REPORTED THAT MANIFOLD W/EXT SET CAME APART, LEAKED, HAD FLOW ISSUES, AND WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT SHE HAD SET (20511E) THAT WAS ATTACHED TO A SMARTSITE EXTENSION SET, 22059E, AND THE LOWER Y-SITE ON THE 20511E WOULD NOT FLUSH AND THEREFORE CAUSED THE 20511E TO POP OFF OF THE 22059E SET. VERBATIM: THIS CAUSED NARCOTIC MEDICATION TO LEAK OUT ONTO THE FLOOR. THE FLUSH ATTACHED WAS A BD FLUSH. ALL TUBING/COMPONENTS WERE SAVED. LOT NUMBERS UNKNOWN. THE 22059E WAS SAVED AND IS STILL ATTACHED TO THE IV CATHETER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 12485549 ↗MalfunctionSep 16, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate
IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ COMBINATION EXTENSION SET WAS BLOCKED/OCCLUDED AT THE LOWER Y-SITE PORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ANESTHESIOLOGIST, TOLD ME SHE HAD A 20511E SET WHERE THE LOWER Y-SITE PORT WOULD NOT FLOW. SHE HAD AN ME2010 SYRINGE TUBING ATTACHED TO THE PORT AND IT WOULD NOT FLOW. SHE TRIED TAKING IT OFF, AND TRYING A STOPCOCK ON IT AND IT STILL WOULD NOT SLOW."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12482141 ↗
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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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