Alaris, SmartSite 20039ERecalls & reported problems
BD Switzerland Sàrl · Extension Set, Smallbore Tubing, Needle-Free Valve, 15 cm (6 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 extension set is an extension tube with a needle-free valve used in IV lines. Reports most often describe the set becoming completely blocked or restricting flow, with some mentioning leaks at the attachment point and connectors that could not be tightened. The database holds 246 malfunction reports, with no deaths and no injuries. 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
- 247
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 247 adverse event reports that list this exact device (DI 07613203011952), received between Feb 8, 2019 and Sep 21, 2026 — classified as 247 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (180 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 Blockage180
- Restricted Flow rate113
- Leak/Splash22
- Free or Unrestricted Flow7
- Defective Component6
- Obstruction of Flow5
- Device Contamination with Chemical or Other Material4
- Disconnection4
Patient problems
- No Clinical Signs, Symptoms or Conditions188
- No Consequences Or Impact To Patient58
- No Patient Involvement3
- Insufficient Information2
- No Information2
- Pain1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 25 most recent of 247 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Material Twisted/Bent
It was reported, Extension set, kinked tubing during use.The following was provided by the initial reporter: During use of the 20039E extension set, an abnormal tubing kink was observed at the exit point of the securement wing. The tubing was sharply bent at the junction between the securement wing and the extension tubing, resulting in deformation of the lumen and potential restriction of fluid flow. The device was replaced upon discovery. There was one occurrence of this issue.Additional information:The LOT number is unknown and unavailable.The Anesthesiology Department identified the issue during use when kinking of the tubing was observed.The fault was identified during infusion when a blockage was observed. The elapsed time before the issue occurred is unknown.The substance being infused at the time of the event is unknown.Unable to confirm whether any damage was observed to the individual set packaging, as the packaging is no longer available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839597 ↗MalfunctionMar 18, 2026Leak/Splash
IT WAS REPORTED BY THE J LOOP WAWS CONTINUOUSLY LEAKING SALINE AND BLOOD AT THE ATTACHMENT POINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24632705 ↗MalfunctionMar 6, 2026Incomplete or Inadequate Connection
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24533783 ↗MalfunctionMar 3, 2026Incomplete or Inadequate Connection
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24492697 ↗MalfunctionMar 3, 2026Incomplete or Inadequate Connection
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE INFUSION SETS (STRAIGHT TYPE) IN THIS BATCH CANNOT BE TIGHTENED. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: PLEASE RETURN THE AFFECTED PRODUCT(S) AND ANY CONNECTING PRODUCTS (WITH ITS ORIGINAL PACKAGING IF POSSIBLE) FOR INVESTIGATION? NO. PLEASE CONFIRM THE LOT NUMBER(S) AFFECTED; IS IT BOTH 25095555 AND 25095556? YES. PLEASE CONFIRM HOW THE FAULT WAS IDENTIFIED? CUSTOMER NOTIFICATION. PLEASE CONFIRM IF THE FAULT WAS IDENTIFIED DURING PRIMING OR DURING INFUSION? IF DURING INFUSION, HOW LONG INTO THE INFUSION? DURING INFUSION, TIME UNKNOWN. PLEASE CONFIRM THE MAKE AND MODEL OF THE CONNECTING PRODUCT(S)? UNKNOWN. PLEASE CONFIRM IF THERE IS ANY VISIBLE DAMAGE ON THE SET, SUCH AS CRACKS, FLASHES OR DEFORMATION OF THE PISTON? UNKNOWN. PLEASE CONFIRM THE EXACT LOCATION OF THE REPORTED FAULT WITHIN THE SET? UNKNOWN. WAS THERE ANY PATIENT HARM? NO. WAS THERE AN UNDER INFUSION? UNKNOWN. COULD YOU PLEASE PROVIDE THE NUMBER OF QUANTITIES AFFECTED? IF APPLICABLE. UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24492689 ↗MalfunctionDec 9, 2025Complete Blockage; Component Misassembled; Complete Blockage; Component Misassembled
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE BLUE SEMI-TRANSPARENT CONNECTOR PORTION OF THE 20039E PINLESS CONNECTOR HAS COMPLETELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23758131 ↗MalfunctionNov 12, 2025Complete Blockage; Complete Blockage
NO FURTHER INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23535246 ↗MalfunctionNov 7, 2025Complete Blockage; Free or Unrestricted Flow; Complete Blockage; Free or Unrestricted Flow
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23497738 ↗MalfunctionNov 7, 2025Complete Blockage; Free or Unrestricted Flow; Complete Blockage; Free or Unrestricted Flow
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23497735 ↗MalfunctionNov 7, 2025Complete Blockage; Free or Unrestricted Flow; Complete Blockage; Free or Unrestricted Flow
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONTROL CLAMP IS NOT TIGHT ENOUGH TO VENT AIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23497556 ↗MalfunctionNov 7, 2025Complete Blockage; Free or Unrestricted Flow; Complete Blockage; Free or Unrestricted Flow
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONTROL CLAMP IS NOT TIGHT ENOUGH TO VENT AIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23497555 ↗MalfunctionNov 6, 2025Flushing Problem; Infusion or Flow Problem
RN PLACING IV PREPROCEDURAL AREA. RN TESTED THE J-LOOP PRIOR TO IV INSERTION. J-LOOP WOULD NOT FLUSH/LET SALINE PASS THROUGH. A DIFFERENT J-LOOP THAT FLUSHED WAS USED FOR IV INSERTION.
Patient problems: Insufficient Information
MAUDE report 23485399 ↗MalfunctionNov 3, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT EXTENSION SET WOULD NOT DRAW OR FLUSH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23448489 ↗MalfunctionOct 31, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONNECTOR LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23444472 ↗MalfunctionSep 5, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNABLE TO BOLUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22978766 ↗MalfunctionSep 4, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22974477 ↗MalfunctionSep 4, 2025Partial Blockage; Obstruction of Flow; Partial Blockage; Obstruction of Flow
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNABLE TO BOLUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22973299 ↗MalfunctionSep 3, 2025Complete Blockage; Complete Blockage
NO ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22959493 ↗MalfunctionSep 3, 2025Complete Blockage; Complete Blockage
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22959480 ↗MalfunctionJul 22, 2025Failure to Disconnect; Failure to Disconnect
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET IS DIFFICULT TO DISCONNECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNHOOKING IV TUBING FROM J LOOP ON A PERIPHERAL IV. THE TUBING UNSCREWED BUT WOULD NOT COME OUT OF THE J LOOP HUB. I PULLED HARDER ON THE CONNECTION PART AND THE PLASTIC TIP THAT GOES INTO THE HUB BROKE OFF AND THEN THE IV STARTED TO BACKFLOW SINCE THERE WAS AN OPEN SPOT IN THE HUB
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22568698 ↗MalfunctionJul 21, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT THEY UNABLE TO FLUSH AFTER MULTIPLE ATTEMPTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22560333 ↗MalfunctionJun 17, 2025Complete Blockage; Infusion or Flow Problem; Complete Blockage; Infusion or Flow Problem
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS CLOGGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT ISSUE RECENTLY WITH THE VALVES. WHEN THEY ATTEMPT FLUSH THE DEVICE, THE VALVE DOES NOT WANT TO OPEN. SOMETIMES THEY CAN GET THE DEVICE TO FUNCTION. OTHER TIMES THEY NEED TO SWITCH OUT THE DEVICE TO GRAB ANOTHER DEVICE. THIS HAS DELAYED CARE FOR THE SHORT TERM WHILE THEY REPLACE THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22235618 ↗MalfunctionSep 25, 2024Defective Component; Defective Component
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET HAD FLOW PROBLEMS THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT RN NOTIFIED THAT SHE AND HER COLLEAGUES HAVE BEEN HAVING ISSUES WITH SOME THEIR J LOOPS NOT WORKING OR FLUSHING PROPERLY. SHE STATED THAT SHE HAD INFORMED XX, CNO REGARDING THIS ISSUE. INITIALLY THEY THOUGH THEIR IVS WERE BAD BUT APPARENTLY, THEY DISCOVERED IT WAS THE J LOOPS. SHE BELIEVES IT MIGHT BE A MANUFACTURER DEFECT. THEY NOTICED THIS ISSUE ABOUT A MONTH AGO, SOMETIME IN JULY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20303133 ↗MalfunctionSep 10, 2024Leak/Splash; Material Separation; Leak/Splash; Material Separation
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET DISCONNECTED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM:THE NEEDLELESS CONNECTOR EASILY POPS OPEN AND CANNOT BE USED TO ADMINISTER MEDICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20179370 ↗MalfunctionSep 9, 2024Defective Device; Defective Device
NO ADDITIONAL INFORMATION RECEIVED. THE NEEDLELESS CONNECTOR CANNOT PUMP WATER AND THE VALVE DOES NOT OPEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20166511 ↗
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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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