Alaris, SmartSite 10010912Recalls & reported problems
BD Switzerland Sàrl · Extension Set, Needle-Free Valve 23 cm (9 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403233531), received between Aug 24, 2021 and Jul 8, 2022 — classified as 2 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
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2022Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE BD SMARTSITE¿ EXTENSION SET WOULDN'T FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE PRODUCT WILL NOT FLUSH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14955880 ↗MalfunctionAug 24, 2021Complete Blockage; Complete Blockage
IT WAS REPORTED EXT SET DEHP FREE 1SS HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SMARTSITE EXTENSION SET NOT FLUSHING PROPERLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12363322 ↗
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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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