Alaris, SmartSite 10108964Recalls & reported problems
BD Switzerland Sàrl · Extension Set, 4-Way Stopcock, Lipid Resistant 2 Needle-Free Valves 97 cm (38 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885403234149), received between Sep 10, 2019 and Jul 29, 2022 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Material Separation” (3 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 18, 2026.
Most reported problems
Device problems
- Material Separation3
- Leak/Splash2
- Labelling, Instructions for Use or Training Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Information2
- No Patient Involvement1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 29, 2022Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
IT WAS REPORTED THAT THE BD SMARTSITE EXTENSION SET SLIDE CLAMP EXPERIENCED PACKAGING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MISLABEL-CUSTOMER STATES THE FOLLOWING: "THERE IS NO ITEM NUMBER ON THIS PRODUCT, IT HAS THE ITEM NUMBER WE SHOULD HAVE RECEIVED ON THE BOX.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15136290 ↗MalfunctionJan 6, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET LEAKED FROM THE DISTAL END AFTER PRIMING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STATES THAT ON MULTIPLE OCCASIONS, THE DISTAL END LEAKS AFTER THE TUBING IS PRIMED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13176283 ↗MalfunctionJan 5, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE DISTAL END OF THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET LEAKED WHEN PRIMING THE TUBING. THIS OCCURRED WITH 2 SETS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE VERY DISTAL END LEAKS AFTER THE TUBING IS PRIMED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13170437 ↗MalfunctionSep 23, 2019Material Separation; Material Separation
IT WAS REPORTED THAT THERE HAVE MULTIPLE EVENTS IN WHICH THE EXTENSION SETS WERE SEPARATING PRIOR TO PATIENT USE. THE IV FLUIDS THAT ARE USED ARE GENERALLY LACTATED RINGERS AND SODIUM CHLORIDE FOR INFUSIONS. THE IV BAGS SIZES RANGE FROM 250ML, 500ML & 1000ML DEPENDING ON AGE OF PATIENTS. CUSTOMER FURTHER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT.
Patient problems: No Patient Involvement
MAUDE report 9107281 ↗MalfunctionSep 10, 2019Material Separation; Material Separation
IT WAS REPORTED THAT THE EXTENSION SET IS ¿FALLING APART¿ WHILE IN USE EVEN WHEN CONNECTIONS ARE TIGHTENED PRIOR TO USE. THE EVENT OCCURRED IN THE PRE-OP, PACU.
Patient problems: No Information
MAUDE report 8981295 ↗MalfunctionSep 10, 2019Material Separation; Material Separation
IT WAS REPORTED THAT THE TUBING WERE SEPARATING AT THE LUER CONNECTION.
Patient problems: No Information
MAUDE report 8981293 ↗
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 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 18, 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