Alaris, SmartSite C25013ERecalls & reported problems
BD Switzerland Sàrl · Extension Set, Smallbore Tubing, Hi-Flo T-Connector with Needle-Free Valve, Needle-Free-Valve (Detachable) 18 cm (7 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 16, 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 10885403235627), received between Mar 12, 2019 and Sep 9, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Complete Blockage1
- Crack1
- Fluid/Blood Leak1
- Restricted Flow rate1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2025Crack; Crack
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS CRACKED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THERE IS A CRACK IN THE TUBING WHERE IT MEETS THE HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22999930 ↗MalfunctionNov 17, 2020Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate
IT WAS REPORTED THAT THE EXT SET HI-FLOW T-CONN W/LL & 2SS COULD NOT BE FLUSHED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SMART SITE EXT SET WOULD NOT FLUSH (TWICE) PT HAD TO BE POKED TWICE BECAUSE NURSE THOUGHT IT WAS AN INFILTRATED LINE."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10855955 ↗MalfunctionMar 12, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT DURING CONTRAST INJECTION USING A NONBD CT INSECTION SYSTEM, THE TUBING BROKE AND CONTRAST LEAKED OUT. THERE WAS NO HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8412220 ↗
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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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