Alaris, SmartSite 2203ERecalls & reported problems
BD Switzerland Sàrl · 13mm Vial Access Device, Needle-Free Valve, 3.5 cm (1.5 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Alaris SmartSite is a needle-free vial access valve. Many of the 136 reports describe the valve blocking flow, leaving plungers hard or impossible to push when fluid is added to medication vials, and some mention leaks. There are no deaths or injuries, and reports fell from 120 in the previous 12 months to 2 in the latest 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 157
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 157 adverse event reports that list this exact device (DI 07613203011792), received between Jun 25, 2019 and Sep 14, 2026 — classified as 157 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (42 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
- Leak/Splash42
- Complete Blockage34
- Infusion or Flow Problem26
- Contamination13
- Defective Component12
- Obstruction of Flow9
- Contamination /Decontamination Problem8
- Break5
Patient problems
- No Clinical Signs, Symptoms or Conditions148
- Insufficient Information9
- Dizziness1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 157 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763190 ↗MalfunctionSep 14, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763188 ↗MalfunctionSep 14, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761337 ↗MalfunctionSep 14, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761334 ↗MalfunctionSep 14, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761332 ↗MalfunctionSep 14, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50757491 ↗MalfunctionSep 14, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50756482 ↗MalfunctionSep 14, 2026Contamination
It was reported that the BD Smartsite Vial Access Device had foreign matter in the fluid path. The following information was provided by the initial reporter: It was reported by customer that there was Foreign Matter. I am sharing a presentation where they are alleging a complaint(s) for vial adapters 2203E and 2203E-0006.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50754085 ↗MalfunctionSep 11, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744352 ↗MalfunctionSep 11, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50740826 ↗MalfunctionSep 11, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50739942 ↗MalfunctionSep 10, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50723091 ↗MalfunctionSep 10, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50723077 ↗MalfunctionSep 10, 2026Contamination /Decontamination Problem
Additional information:No AE reported 10-Nov-25 pt. to report that one vial had some black debris.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722265 ↗MalfunctionSep 10, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722264 ↗MalfunctionSep 10, 2026Contamination /Decontamination Problem
It was reported that the BD Smartsite Vial Access Device had foreign matter in the fluid path.The following information was provided by the initial reporter: Foreign Material - In Lyo/Powder Product - After Reconstitution.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721204 ↗MalfunctionSep 10, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718370 ↗MalfunctionSep 10, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50703626 ↗MalfunctionSep 10, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50703625 ↗MalfunctionSep 10, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50703624 ↗MalfunctionSep 9, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702910 ↗MalfunctionApr 13, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED, "A PIECE OF WHITE CONTAMINANT LOCATED INSIDE THE BLUE AREA OF THE ADAPTER". NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24859858 ↗MalfunctionFeb 9, 2026Obstruction of Flow
IT IS REPORTED FLOW ISSUES, OCCLUSION. VERBATIM: COMPLAINT FOR PRESSURE IRREGULARITY THAT NEED ADDITIONAL TESTING. CUSTOMER REPORTS NO DAMAGE TO VIAL ADAPTOR OR SYRINGE AND EVERYTHING WAS REPORTED TO HAVE BEEN ATTACHED CORRECTLY. THE CUSTOMER REPORTS WHEN CONNECTED THE PLUNGER WOULD NOT PRESS DOWN. WHEN DISCONNECTED FROM VIAL ADAPTOR THE PLUNGER WORKED FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24292014 ↗MalfunctionOct 15, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD ALARIS SMARTSITE NEEDLE FREE VALVE WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THEY WERE ATTEMPTING TO INJECT THE STERILE WATER INTO THE VIAL, THE PLUNGER WAS DIFFICULT TO PUSH AND WAS STUCK PRIOR TO INJECTING THE FULL AMOUNT OF STERILE WATER AND TOOK THE SECOND ADAPTER AND USED THAT AFTER THE STERILE WATER SYRINGE PLUNGER BECAME STUCK AND THEN I WAS ABLE TO INJECT THE REST OF THE STERILE WATER IN THE VIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23287357 ↗MalfunctionOct 15, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD ALARIS SMARTSITE NEEDLE FREE VALVE WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY THE CUSTOMER THAT THEY WENT TO INJECT THE STERILE WATER INTO THE VIAL BUT WAS MET WITH COMPLETE RESISTANCE AND UNABLE TO PUSH THE FLUID INTO THE VIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23287162 ↗
Other Set, i.V. Fluid transfer devices
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- EXACTAMIX H938739Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall972 reports
- EXACTAMIX H938741Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall710 reports
- EXACTAMIX H938737Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall607 reports
- EXACTAMIX H938724Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall513 reports
- EXACTAMIX H938173Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls260 reports
- EXACTAMIX H938176Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls232 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.
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