Alaris, SmartSite 20061ERecalls & reported problems
BD Switzerland Sàrl · Extension Set, 2 Needle-Free Valves 17.8 cm (7 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613203011877), received between Feb 2, 2021 and Feb 2, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 2, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 100 LGE BORE Y EXT W/VP 3 SL CL SETS HAD DEFECTIVE TUBING THAT WERE SHORTER THAN THE ADVERTISED "7 INCHES IN LENGTH". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RECEIVED PRODUCT BUT ONLINE DIAGRAM OF PRODUCT SEEMS TO BE MISLEADING AS THE TUBING NEEDS TO BE LONGER. THE TUBING IS UNDER 7 INCHES IN LENGTH."
Patient problems: No Patient Involvement
MAUDE report 11269618 ↗
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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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