Alaris, SmartSite 30207ERecalls & reported problems
BD Switzerland Sàrl · Dual-Port Extension Set, Check Valve Needle-Free Valve 2 Luer Lock Connectors Y Connector, 43 cm (17 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613203011495), received between Nov 14, 2022 and Sep 16, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Backflow” (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. 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
- Backflow1
- Complete Blockage1
- Component Misassembled1
- Component Missing1
- Defective Component1
- Failure to Disconnect1
- Failure to Prime1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Backflow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50788808 ↗MalfunctionJan 2, 2025Defective Component; Component Misassembled; Defective Component; Component Misassembled
IT WAS REPORTED THAT BD WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM 2 FAULTY ONES - THE BUNG IS UP-SIDE DOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21055338 ↗MalfunctionJun 21, 2024Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD ALARIS SMARTSITE DUAL-PORT EXTENSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: NO FLUID RUNNING WHEN CONNECTED TO EXTENSION SET. TESTED WITH SYRINGE AND FOUND TO BE BLOCKED. SEVERAL FROM THE SAME BATCH WERE FOUND TO BE BLOCKED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19583796 ↗MalfunctionOct 12, 2023Leak/Splash; Leak/Splash
ADDED ON 04 OCT 2023 (B)(6) INCIDENT OCCURRED POST OPERATION, EXTENSION SET CONNECTED TO CVC. EXTENSION SET FALL APART WITH NO TENSION ON LINE. BREAK OCCURRED AT JUNCTION OF LINE AND SIDE ARM. OBSERVED BLOOD LEAKING OUT OF BROKEN PORT LINE. NO HARM TO PATIENT. POTENTIAL BLOOD LOSS OR AIR EMBOLUS. OCCURRED ON TWO OCCASIONS, ON TWO DIFFERENT WARDS, BUT WASN'T ABLE TO PROVIDE FURTHER INFORMATION TO THIS. ON THESE TWO DIFFERENT OCCASIONS, THE NURSING STAFF USING EXTENSION SET ON PATIENT NOTICED WHEN CONNECTED, IT WAS CAUSING LEAKING AND BLOOD TO RUN BACK INTO THE LINE. THEY DISPOSED OF THE AFFECTED EXTENSION SET AND USED ANOTHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17927054 ↗MalfunctionOct 11, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE DUAL-PORT EXTENSION SET WAS DAMAGED, BREAK CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT INCIDENT OCCURRED POST OPERATION. EXTENSION SET CONNECTED TO CVC. EXTENSION SET FALL APART WITH NO TENSION ON LINE. BREAK OCCURRED AT JUNCTION OF LINE AND SIDE ARM. OBSERVED BLOOD LEAKING OUT OF BROKEN PORT LINE. POTENTIAL BLOOD LOSS OR AIR EMBOLUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17916329 ↗MalfunctionOct 11, 2023Material Separation; Material Separation
NO ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17913488 ↗MalfunctionFeb 23, 2023Component Missing; Component Missing
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE DUAL-PORT EXTENSION SET WAS MISSING COMPONENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT MISSING COMPONENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16433440 ↗MalfunctionDec 1, 2022Failure to Prime; Failure to Prime
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE DUAL-PORT EXTENSION SET WAS UNABLE TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DUAL PORT EXTENSION PORT WAS UNABLE TO PRIME DUE TO ANTI-REFLUX VALVE NOT WORKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15893786 ↗MalfunctionNov 14, 2022Failure to Disconnect; Failure to Disconnect
IT WAS REPORTED WHILE USING BD EXT SET W/ VLV PORT & LL THE DEVICE WAS DIFFICULT TO DISCONNECT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECEIVED ANOTHER COMPLAINT FROM OUR WARDS RE NOT BEING ABLE TO DISCONNECT THE LINES FROM THE CANNULA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15789729 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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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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