BD SmartSite 42405E-07Recalls & reported problems
BD Switzerland Sàrl · Gravity Set 2 Check Valves, 3 Needle-Free Valves, 2 Split Septum Ports, 4-Way Stopcock - 2 Ganged Vented/Nonvented, 313 cm (123 in) · Class 2
All models of BD SmartSite (29)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10885403238611), received between Jul 23, 2018 and Sep 10, 2018 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Material Separation” (15 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
- Material Separation15
- Fluid/Blood Leak14
Patient problems
- No Consequences Or Impact To Patient15
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2018Material Separation; Material Separation
THE CUSTOMER REPORTED THE SET SEPARATED AT A LOCATION OTHER THAN NEXT TO THE STOCK-COCK. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7860603 ↗MalfunctionSep 7, 2018Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
THE CUSTOMER REPORTED SEPARATION AND LEAKING AT BOTH CONNECTION POINTS ATTACHING TO THE STOP-COCK DURING PATIENT USE. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7856019 ↗MalfunctionJul 24, 2018Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
THE CUSTOMER REPORTED THAT WHILE ATTACHED TO THE PATIENT, THE SET CAME APART AT THE STOPCOCK AND LEAKED. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7715170 ↗MalfunctionJul 24, 2018Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
THE CUSTOMER REPORTED THE SET CAME APART AT THE STOPCOCK AND LEAKED WHILE ATTACHED TO THE PATIENT. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7715169 ↗MalfunctionJul 24, 2018Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
THE CUSTOMER REPORTED THAT WHILE ATTACHED TO THE PATIENT, THE SET CAME APART AT THE STOPCOCK AND LEAKED. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7715121 ↗MalfunctionJul 24, 2018Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
THE CUSTOMER REPORTED THAT WHILE ATTACHED TO THE PATIENT, THE SET CAME APART AT THE STOPCOCK AND LEAKED. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7715057 ↗MalfunctionJul 24, 2018Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
THE CUSTOMER REPORTED THAT WHILE ATTACHED TO THE PATIENT, THE SET CAME APART AT THE STOPCOCK AND LEAKED. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7715055 ↗MalfunctionJul 24, 2018Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
THE CUSTOMER REPORTED THAT WHILE ATTACHED TO THE PATIENT, THE SET CAME APART AT THE STOPCOCK AND LEAKED. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7714997 ↗MalfunctionJul 24, 2018Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
THE CUSTOMER REPORTED THAT WHILE ATTACHED TO THE PATIENT, THE SET CAME APART AT THE STOPCOCK AND LEAKED. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7714994 ↗MalfunctionJul 24, 2018Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
THE CUSTOMER REPORTED THAT WHILE ATTACHED TO THE PATIENT, THE SET CAME APART AT THE STOPCOCK AND LEAKED. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7714992 ↗MalfunctionJul 24, 2018Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
THE CUSTOMER REPORTED THAT WHILE ATTACHED TO THE PATIENT, THE SET CAME APART AT THE STOPCOCK AND LEAKED. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7714890 ↗MalfunctionJul 24, 2018Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
THE CUSTOMER REPORTED THAT WHILE ATTACHED TO THE PATIENT, THE SET CAME APART AT THE STOPCOCK AND LEAKED. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7714888 ↗MalfunctionJul 23, 2018Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
THE CUSTOMER REPORTED THE SET CAME APART AT THE STOPCOCK AND LEAKED. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7712429 ↗MalfunctionJul 23, 2018Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
THE CUSTOMER REPORTED THE SET CAME APART AT THE STOPCOCK AND LEAKED. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7712425 ↗MalfunctionJul 23, 2018Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
THE CUSTOMER REPORTED THE SET CAME APART AT THE STOPCOCK AND LEAKED. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7712389 ↗
Other Set, administration, intravascular devices
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- 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 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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