BD SmartSite 10050187Recalls & reported problems
BD Switzerland Sàrl · Gravity Set, 4-Way Stopcock- 4 Ganged 2 Needle-Free Valves Vented/Nonvented 188 cm (74 in) · Class 2
All models of BD SmartSite (29)
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 10885403234118), received between Mar 11, 2021 and Mar 11, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Complete Blockage” (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
- Complete Blockage1
- Inaccurate Delivery1
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.
MalfunctionMar 11, 2021Complete Blockage; Inaccurate Delivery; Complete Blockage; Inaccurate Delivery
IT WAS REPORTED THAT THE GRA SET 60DP 2SS W/EXT SET 4G-4W STPCK HAD FLOW ISSUES THAT ALLOWED MEDICATION TO ENTER THE INTRAVENOUS FLUID BAG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PRODUCT IN QUESTION IS MFG # 10050187 AND HAS BEEN REMOVED FROM THE CARDIOTHORACIC OPERATING ROOMS AND PREOP DUE TO CONCERNS WITH THE TUBING ALLOWING MEDICATION MAKING IT INTO THE INTRAVENOUS FLUID BAG."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11467364 ↗
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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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