BD SmartSite C42013ERecalls & reported problems
BD Switzerland Sàrl · Gravity Set, Check Valve, Needle-Free Valve, 2 Split Septum Ports, 2 One-Way Valves, Vented/Nonvented 330 cm (130 in) · Class 2
All models of BD SmartSite (29)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885403235719), received between Apr 23, 2019 and Apr 23, 2019 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).
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 Leak4
- Material Separation4
Patient problems
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
IT WAS REPORTED THAT THE TUBING SET SEPARATED AND LEAKED DURING A NORMAL SALINE AND IV INDUCTION AGENT INFUSION IN THE ANESTHESIA DEPARTMENT WHILE IN USE ON AN ADULT PATIENT. THE CUSTOMER STATED THAT THERE WAS NO PATIENT HARM CAUSED FROM THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8542165 ↗MalfunctionApr 23, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
IT WAS REPORTED THAT THE TUBING SET SEPARATED AND LEAKED DURING A NORMAL SALINE AND IV INDUCTION AGENT INFUSION IN THE ANESTHESIA DEPARTMENT WHILE IN USE ON AN ADULT PATIENT. THE CUSTOMER STATED THAT THERE WAS NO PATIENT HARM CAUSED FROM THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8541146 ↗MalfunctionApr 23, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
IT WAS REPORTED THAT THE TUBING SET SEPARATED AND LEAKED DURING A NORMAL SALINE AND IV INDUCTION AGENT INFUSION IN THE ANESTHESIA DEPARTMENT WHILE IN USE ON AN ADULT PATIENT. THE CUSTOMER STATED THAT THERE WAS NO PATIENT HARM CAUSED FROM THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8541091 ↗MalfunctionApr 23, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
IT WAS REPORTED THAT THE TUBING SET SEPARATED AND LEAKED DURING IV SEDATION IN THE ANESTHESIA DEPARTMENT WHILE IN USE ON A GERIATRIC PATIENT. THE CUSTOMER STATED THAT THERE WAS NO PATIENT HARM CAUSED FROM THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8540454 ↗
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- 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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