Alaris, SmartSite 25202ERecalls & reported problems
BD Switzerland Sàrl · Extension Set, 4-Way Stopcock, Needle-Free Valve, 94 cm (37 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885403235146), received between Apr 1, 2022 and Jul 3, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (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.
Reports received per month
Most reported problems
Device problems
- Complete Blockage3
- Fluid/Blood Leak1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNABLE TO FLUSH AFTER MULTIPLE ATTEMPTS. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: WAS THERE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THIS EVENT? THERE HAVE BEEN NO INCIDENCE OF PATIENT HARM, COMPLICATION, OR NEGATIVE OUTCOME. COULD YOU PLEASE CONFIRM IF THE EVENT OCCURRED ON THE SAME DATE FOR ALL THREE LOT NUMBERS? MULTIPLE DATES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22401165 ↗MalfunctionJul 3, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNABLE TO FLUSH AFTER MULTIPLE ATTEMPTS. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: WAS THERE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THIS EVENT? THERE HAVE BEEN NO INCIDENCE OF PATIENT HARM, COMPLICATION, OR NEGATIVE OUTCOME. COULD YOU PLEASE CONFIRM IF THE EVENT OCCURRED ON THE SAME DATE FOR ALL THREE LOT NUMBERS? MULTIPLE DATES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22401161 ↗MalfunctionJul 3, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNABLE TO FLUSH AFTER MULTIPLE ATTEMPTS ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: WAS THERE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THIS EVENT? THERE HAVE BEEN NO INCIDENCE OF PATIENT HARM, COMPLICATION, OR NEGATIVE OUTCOME. COULD YOU PLEASE CONFIRM IF THE EVENT OCCURRED ON THE SAME DATE FOR ALL THREE LOT NUMBERS? MULTIPLE DATES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22396889 ↗MalfunctionJun 13, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD EXTENSION SET WAS LOOSE. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM MATERIAL #25202E, LOT #25029340. IT WAS REPORTED BY CUSTOMER THAT THE EXTENSION TUBING COMING LOOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22206826 ↗MalfunctionApr 1, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET LEAKED NEAR THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CLIENT: "EXTENSION SET LEAKING - "WE HAVE BEEN SEEING SOME IV SET LEAKAGE IT SEEMS IT¿S A THE POINT WHERE THE TUBING IS GOING INTO THE HUB. IT IS ITEM 25202E THIS LOT NUMBER IS (10) 21129276."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13980544 ↗
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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.
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