BD SmartSite 10425228Recalls & reported problems
BD Switzerland Sàrl · Gravity Set, Check Valve, 4-Way Stopcock, 4 Needle-Free Valves, Vented/Nonvented 251 cm (99 in) · Class 2
All models of BD SmartSite (29)
Data updated Oct 16, 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 10885403234248), received between Sep 5, 2019 and Oct 1, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
- Material Puncture/Hole1
- Material Separation1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 1, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
IT WAS REPORTED THAT DURING AN INFUSION, THE PATIENT WAS CRITICAL AND PRESSORS WERE BEING RUN IN THE IV. AT SOME POINT, THE TUBING BECAME DETACHED AND FLUID RAN ONTO THE FLOOR. IT IS UNKNOWN HOW MUCH MEDICATION THE PATIENT DID RECEIVE. THE VITAL SIGNS REMAINED THE SAME. NEW TUBING AND MEDICATION WAS STARTED. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9140020 ↗MalfunctionSep 5, 2019Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE TUBING HAS A HOLE IN IT MIDLINE. IT WAS CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8967408 ↗
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- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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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