Alaris, SmartSite 10015171Recalls & reported problems
BD Switzerland Sàrl · Gravity Set, Needle-Free Valve Vented/Non-Vented 264 cm (104 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 10885403233975), received between Feb 25, 2025 and Feb 25, 2025 — 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 25, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT WHEN STABBING INTO THE THAWED PRODUCT WITH THE CAR T SPIKE INTO THE CAR- T PRODUCT, AS THEY INVERTED IT, SAW THAT THERE WAS A LEAK BELOW THE SPIKE IN THE BASE OF THE SPIKE. NOTED A DRIP, RE-INVERTED IT. THE STEM CELL PROCESSING LAB HAD TO CUT THE TUBING BELOW THE DRIP CHAMBER TO DETERMINE THE AMOUNT OF PRODUCT LOSS, WILL FIND A HEMOSTAT IN PLACE AT THE POINT OF THE TUBING MANIPULATION. THEY LOST 2.3 MLS OF CARVYKTI PRODUCT. THE LEAK OCCURRED BELOW THE TUBING SPIKE BUT ABOVE THE DRIP CHAMBER. THIS WAS NOTED IMMEDIATELY UPON SPIKING THE BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21458769 ↗
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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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