Alaris, SmartSite 30842ERecalls & reported problems
BD Switzerland Sàrl · Extension Set, Smallbore Tubing Segment Check Valve Needle-Free Valve 33 cm (13 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 16, 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 07613203023450), received between Dec 23, 2020 and Dec 23, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Infusion or Flow Problem” (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 16, 2026.
Most reported problems
Device problems
- Infusion or Flow Problem1
- Leak/Splash1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 23, 2020Leak/Splash; Infusion or Flow Problem; Leak/Splash; Infusion or Flow Problem
IT WAS REPORTED THAT THE EXT SET, SS Y, CHECK VALVE EXPERIENCED LEAKAGE AND TUBING EXPANSION/BALLOONING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NUMBER OF AFFECTED SAMPLES UNKNOWN, CUSTOMER HAS 12 BOXES (1200 EACHES). CUSTOMER SUBMITTING INTERNAL INCIDENT REPORT TO CLINICAL PRODUCT MANAGERS, AWAITING MORE DETAILS. AS PER PHONE MESSAGE ONLY A FEW INCIDENTS HOWEVER CUSTOMER HAS DECIDED TO PULL ALL STOCK OUT OF CLINICAL USE PENDING INVESTIGATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11070162 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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