Alaris, SmartSite 2000EARecalls & reported problems
BD Switzerland Sàrl · Needle-Free Valve · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613203012751), received between Jul 31, 2018 and Aug 3, 2023 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (6 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
- Complete Blockage6
- Fluid/Blood Leak3
- Leak/Splash3
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Information2
- Hemorrhage/Blood Loss/Bleeding1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2023Complete Blockage; Complete Blockage
IT WAS REPORTED WHILE USING BD ARTERIAL SMARTSITE¿ NEEDLE-FREE VALVE THERE WAS A CLOG. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PER CUSTOMER, ¿WE ARE HAVING PROBLEMS WITH THE BD 2000EA LUER LOCK SITES. THEY ARE OCCLUDING AND KEEPING THE FLUIDS FROM RUNNING INTO THE PATIENT. NURSING STAFF AND THE CNO HAVE REPORTED THAT THE BD 2000EA LUER LOC SITES WILL NOT LET THE FLUIDS RUN. THEY HAVE UNHOOKED THE TUBINGS AND THE FLUIDS WILL RUN FINE IF NOT GOING THROUGH THE BD LUER LOCK SITE. I WOULD LIKE TO RETURN WHAT I HAVE PURCHASED. I HAVE 4 CASES STILL IN THEIR ORIGINAL BOXES AND THEN APPROXIMATELY ANOTHER CASE IN ZIPLOCK BAGS THAT WE DISPENSE WITH . THE NURSING DEPT AND ER WILL PROBABLY HAVE MORE BUT I DON'T KNOW THAT NUMBER YET. WOULD YOU BE ABLE TO TELL ME HOW MANY WE HAVE PURCHASED FROM CARDINAL? I HAVE PURCHASED FROM SHARED ALSO AND AM WORKING WITH THEM ALSO.¿ COULD YOU PLEASE HELP TO PROVIDE THE EXACT QUANTITY OF AFFECTED BATCH? I HAVE 8 CASES OF 10, STILL IN BOXES. I HAVE 96 EA IN A ZIPLOCK THAT HAS BEEN RETURNED FROM DEPARTMENTS. 2. IS THERE ANY SAMPLE AVAILABLE? IF YES, KINDLY PROVIDE THE FACILITY ADDRESS FOR US TO GENERA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17452676 ↗MalfunctionJun 22, 2023Complete Blockage; Complete Blockage
IT WAS REPORTED THAT DURING USE WITH BD SMARTSITE NEEDLE-FREE VALVE THE DEVICE WAS OCCLUDED. PATIENT 3 OF 3. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿WE ARE HAVING PROBLEMS WITH THE BD 2000EA LUER LOCK SITES. THEY ARE OCCLUDING AND KEEPING THE FLUIDS FROM RUNNING INTO THE PATIENT. NURSING STAFF AND THE CNO HAVE REPORTED THAT THE BD 2000EA LUER LOC SITES WILL NOT LET THE FLUIDS RUN. THEY HAVE UNHOOKED THE TUBINGS AND THE FLUIDS WILL RUN FINE IF NOT GOING THROUGH THE BD LUER LOCK SITE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17181758 ↗MalfunctionJun 22, 2023Complete Blockage; Complete Blockage
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17181757 ↗MalfunctionMay 26, 2023Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE BD SMARTSITE NEEDLE-FREE VALVE EXPERIENCED OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY ARE OCCLUDING AND KEEPING THE FLUIDS FROM RUNNING INTO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17013876 ↗MalfunctionJul 15, 2022Complete Blockage; Complete Blockage
IT WAS REPORTED THAT FOUR BD SMARTSITE NEEDLE-FREE VALVE EXPERIENCED OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SEASONED NURSES HAVE HAD DIFFICULTY IN FLUSHING THROUGH THE SMART SITE, THIS HAPPENED AT LEAST THREE TIMES OVER THE LAST SEVERAL WEEKS AND IS A CONCERN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15033578 ↗MalfunctionJan 10, 2022Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE BD SMARTSITE NEEDLE-FREE VALVE EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING OF BLOOD BETWEEN THE SMARTSITE AND THEIR MICROCLAVE. WE BELIEVE IT WAS EITHER A CRACK IN THE SMARTSITE OR THE MICROCLAVE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 13203932 ↗MalfunctionAug 30, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE NDLELESS VLV ADPT ARTERIAL EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAD A REPORT FROM THE CHARGE NURSE OF SOME CONCERNING ISSUE WHEN THEY HAD A TEXIUM ADAPTOR CONNECTED TO A 2000EA ADAPTOR. APPARENTLY THERE WAS A LEAK WHILE FLUID WAS PASSING BETWEEN THE TWO, BUT I HAVE REPORTS THEY HAD BEEN USING ONE OF THE 2000EA ON THE PICC TO CHECK FOR BLOOD RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12389086 ↗MalfunctionJun 16, 2021Complete Blockage; Complete Blockage
IT WAS REPORTED THAT NDLELESS VLV ADPT ARTERIAL HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THEY ARE HAVING ISSUES WITH SMARTSITE NEEDLE-FREE VALVES NOT ALLOWING ANYTHING TO FLOW THROUGH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12008598 ↗MalfunctionOct 20, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 2 NDLELESS VLV ADPT ARTERIAL EXPERIENCED DEVICE DAMAGE/DEFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 2000EA, BATCH NO: 20076485. THE BASE OF THE 200EA CRACKED WHEN MOUNTED ON MECHANICAL PUMP 2 TIMES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10703504 ↗MalfunctionMay 1, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE NEEDLE FREE VALVE LEAKED AT CONNECTION TO THE EASYPUMP. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.
Patient problems: No Information
MAUDE report 10017349 ↗MalfunctionMay 1, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE NEEDLE FREE VALVE LEAKED AT CONNECTION TO THE EASYPUMP. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.
Patient problems: No Information
MAUDE report 10017348 ↗MalfunctionJul 31, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT WHEN DISCONNECTING A DOXORUBICIN IV PUSH, IT LEAKED ON THE OUTSIDE TOP OF THE VALVE. THE CUSTOMER STATES "THIS HAPPENS WITH EVERY USE" HOWEVER NO DETAILS WERE GIVEN FOR OTHER SPECIFIC EVENTS THEREFORE, THIS IS THE ONLY FILE. THE LEAK COULD BE WITH EVERY CHEMOTHERAPEUTIC DRUG BUT THE DOXORUBICIN IS ORANGE AND CAN BE SEEN. THERE WAS NO PATIENT HARM..
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7735906 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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