Alaris, SmartSite 20059ERecalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 07613203012317), received between Jul 3, 2019 and Jun 10, 2026 — classified as 84 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (54 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 84 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2026Compatibility Problem

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EXTENSION SET WILL NOT PULL BLOOD BACK. IV WAS STARTED AND HAD BLOOD RETURN. EXTENSION SET WAS CONNECTED WITH VACUTAINER AND LABS WOULD NOT DRAW BACK. WHEN EXTENSION SET WAS REMOVED, BLOOD STARTS COMING OUT OF THE INSYTE AUTOGUARD. IF A FLUSH OR SYRINGE IS HOOKED UP TO THE LINE INSTEAD OF THE VACUTAINER, THERE ARE NO PROBLEMS ASPIRATING BACK FOR BLOOD AND THE EXTENSION SET WORKS PROPERLY. THE SMARTSITE VALVE EXTENSION SET SEEMS TO COME SEALED ON THE VALVE END FROM THE MANUFACTURING PLANT. IN ORDER TO BREAK THIS SEAL, A FLUSH NEEDS TO BE HOOKED UP AND THE LINE NEEDS TO BE PRIMED WITH SALINE PRIOR TO USE. WE OBSERVED THE LAB DRAW PRACTICE ON THE L&D UNIT AND IDENTIFIED THAT THE CLINICIANS DIRECT CONNECTING A VACUTAINER BEFORE A FLUSH/SYRINGE WERE THE ONES EXPERIENCING ISSUES. THE VACUTAINER THREAD IS NOT DEEP ENOUGH TO BREAK THE SEAL (2 THREAD COUNTS). THE FLUSH SYRINGE HAS AN EXTRA THREAD (3 THREAD COUNTS), MAKING IT A DEEPER CONNECTION TO BREAK THE SEAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25459885 ↗
• MalfunctionMay 29, 2026Complete Blockage

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT EXTENSION SET WITH CONNECTOR WOULD NOT FLUSH OR DRAW LABS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25326541 ↗
• MalfunctionMay 26, 2026Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EXTENSION SET WOULD NOT FLUSH AND COULD NOT PULL LABS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25292520 ↗
• MalfunctionMay 12, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT EXTENSION SET DID NOT WORK TO FLUSH OR DRAW BLOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25153059 ↗
• MalfunctionMay 12, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT EXTENSION SET DID NOT WORK TO DRAW BLOOD OR FLUSH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25153058 ↗
• MalfunctionMay 12, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT EXTENSION SET DID NOT WORK TO DRAW BLOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25153056 ↗
• MalfunctionMay 11, 2026Obstruction of Flow

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD SMARTSITE NEEDLE-FREE VALVE (REF# 20059E) (LOT# (10)25116104). EXTENSION SET DID NOT WORK TO DRAW BLOOD. IV WAS GOOD AND FLUSHING. THERE WERE NOT ANY ADVERSE OR SERIOUS INJURY TO PATIENT OR HEALTHCARE PROFESSION WITH BD PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137719 ↗
• MalfunctionMay 3, 2026Connection Problem

  IT WAS REPORTED THAT BD SMARTSITE SECONDARY SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT SOMETIMES THE BLUE CONNECTOR WILL NOT OPEN AND ALLOW FLUID TO FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062497 ↗
• MalfunctionApr 27, 2026Connection Problem

  IT WAS REPORTED THAT BD SMARTSITE SECONDARY SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT SOMETIMES THE BLUE CONNECTOR WILL NOT OPEN AND ALLOW FLUID TO FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25007981 ↗
• MalfunctionMar 31, 2026Complete Blockage

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE SMARTSITE EXTENSION SET MALFUNCTION, DOES NOT INFUSE, RN ATTEMPT TO TIGHTEN AND ADJUST, MULTIPLE EXTENSION SETS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746537 ↗
• MalfunctionMar 10, 2026Obstruction of Flow

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EXTENSION SETS NOT ALLOWING BLOOD COLLECTION FOR LAB WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560826 ↗
• MalfunctionJul 30, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT FAILED TO FLUSH SMART SITE EXTENSION SET NEEDLE-FREE VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22671675 ↗
• MalfunctionJul 8, 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 LOT NUMBERS? MULTIPLE DATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22438718 ↗
• MalfunctionJul 8, 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 LOT NUMBERS? MULTIPLE DATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22438684 ↗
• MalfunctionJul 8, 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 LOT NUMBERS? MULTIPLE DATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22438681 ↗
• MalfunctionJul 1, 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 LOT NUMBERS? MULTIPLE DATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22378655 ↗
• MalfunctionJul 1, 2025Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22378651 ↗
• MalfunctionOct 23, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: XXX STATED THAT THEY HAVE A HANDFUL OF EXTENSION SETS THAT WILL NOT FLUSH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17992928 ↗
• MalfunctionOct 10, 2023Burst Container or Vessel; Burst Container or Vessel

  NO ADDITIONAL INFORMATION. MATERIAL #: 20059E, BATCH #: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THEY CONTINUE TO HAVE TROUBLE WITH THE 20059E IV EXTENSION SETS BURSTING. THIS IS A PROBLEM THAT POPPED UP ABOUT 6 MONTHS AGO AND IS NOW BEING DOCUMENTED BY THE CT STAFF. HE/SHE HAVE SEVERAL EXTENSIONS THAT THEY CAN SHOW YOU. THIS WAS NEVER A PROBLEM IN THE PAST. WHILE TRYING TO INJECT CONTRAST USING A POWER INJECTOR AND THE TUBING WAS NOT ABLE TO HANDLE THE PRESSURE AND POPPED OPEN X 3. THEY REPLACED THE TUBING 3 TIMES IN THE PATIENTS IV. EACH TIME WE INJECTED THE TUBE PRESSURED UP AND POPPED OPEN. THEY ARE RUNNING THESE SETS AT 250 PSI. VERBATIM: WE CONTINUE TO HAVE TROUBLE WITH THE 20059E IV EXTENSION SETS BURSTING. THIS IS A PROBLEM THAT POPPED UP ABOUT 6 MONTHS AGO AND IS NOW BEING DOCUMENTED BY THE CT STAFF. I HAVE SEVERAL EXTENSIONS THAT WE CAN SHOW YOU. THIS WAS NEVER A PROBLEM IN THE PAST. WHILE TRYING TO INJECT CONTRAST USING A POWER INJECTOR AND THE TUBING WAS NOT ABLE TO HANDLE THE PRESSURE AND POPPED OPEN X 3. WE REPLACED THE TUBING 3 TIMES IN THE PATIENTS IV. EACH TIME WE INJECTED THE TUBE PRESSURED UP AND POPPED OPEN. WE ARE RUNNING THESE SETS AT 250 PSI.

  Patient problems: Insufficient Information

  MAUDE report 17909838 ↗
• MalfunctionJul 11, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT DURING CT INFUSTION WITH BD SMARTSITE¿ EXTENSION SET, 1 SMARTSITE¿ NEEDLE-FREE CONNECTOR THE TUBING WAS DEFECTIVE. THIS IS THE 1ST OF 2 EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MY CLINICIANS HAD TWO OF OUR J LOOPS (SMARTSITE¿ EXTENSION SET) POP DURING A CT INFUSION. THEY USED 3.5 PRESSURE. THEY DETERMINED THE IV CATHETER WORKED ON HUB, SO THAT WASN'T THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17299312 ↗
• MalfunctionJul 10, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT DURING CT INFUSION WITH BD SMARTSITE¿ EXTENSION SET, 1 SMARTSITE¿ NEEDLE-FREE CONNECTOR THE TUBING WAS DEFECTIVE. THIS IS THE 2ND OF 2 EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MY CLINICIANS HAD TWO OF OUR J LOOPS (SMARTSITE¿ EXTENSION SET) POP DURING A CT INFUSION. THEY USED 3.5 PRESSURE. THEY DETERMINED THE IV CATHETER WORKED ON HUB, SO THAT WASN'T THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17295236 ↗
• MalfunctionJun 28, 2023Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE BD SMARTSITE¿ EXTENSION SET EXPERIENCED DIFFICULTY TOTO DISCONNECT DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS A MASSIVE RECALL FROM 2021 INDICATING DIFFICULTY IN OPENING THE NEEDLE FREE CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17221406 ↗
• MalfunctionJun 28, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD SMARTSITE¿ EXTENSION SET EXPERIENCED OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LDRP TOLD ME TO SEND YOU THIS HAS A LOT NUMBER THEY CAN'T GET NO FLUID TO COME OUT OF THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17221397 ↗
• MalfunctionDec 28, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 3 OF THE BD SMARTSITE¿ EXTENSION SET ARE UNABLE TO FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE HAVING SIGNIFICANT ISSUES WITH THE SMARTSITE EXTENSION SETS REF 20059E. ABOUT EVERY FOURTH OR FIFTH ONE WE ARE UNABLE TO FLUSH THEM. WE TRY TO FLUSH WITH A SYRINGE AND SOMETIMES IT WORKS, SOMETIMES IT DOESN'T. I HAVE TWO HERE THAT WE CAN GIVE YOU IF YOU NEED TO LOOK AT THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16063716 ↗
• MalfunctionDec 27, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ALARIS¿ SMARTSITE¿ EXTENSION SETS HAD FLOW ISSUES DURING THE FLUSHING PROCESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ARE HAVING SIGNIFICANT ISSUES WITH THE SMARTSITE EXTENSION SETS REF 20059E. ABOUT EVERY FOURTH OR FIFTH ONE WE ARE UNABLE TO FLUSH THEM. WE TRY TO FLUSH WITH A SYRINGE AND SOMETIMES IT WORKS, SOMETIMES IT DOESN'T."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16057400 ↗