BD SmartSite 42503ERecalls & reported problems
BD Switzerland Sàrl · Gravity Set, Check Valve 3 Needle-Free Valves, 4-Way Stopcock, Vented/ Nonvented 262 cm (103 in) · Class 2
Data updated Oct 13, 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 10885403235399), received between Aug 10, 2022 and Jan 3, 2023 — classified as 2 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 3, 2023Material Separation; Material Separation
IT WAS REPORTED THAT 2 BD GRAV 100DP CV 2SS 4W STD STOPCOCK EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TWICE WHEN SETTING UP IV TUBING, THE TUBING DISCONNECTED IMMEDIATELY BELOW THE TUBING CHAMBER. IV FLUID BAG AND TUBING CHANGED APPROPRIATELY FOR PATIENT CARE AND OTHER DISCARDED. NOTE: TUBING WAS NOT EXPIRED NOR APPEARED DAMAGED IN ANYWAY. NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16091963 ↗MalfunctionAug 10, 2022Break; Break
IT WAS REPORTED THAT THE BD GRAV 100DP CV 2SS 4W STD STOPCOCK EXPERIENCED THE TUBING BREAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING KEEPS BREAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15198820 ↗
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page