Alaris, SmartSite 20019ERecalls & reported problems

Summary

The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 07613203012010), received between Aug 1, 2018 and Apr 28, 2026 — classified as 97 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (57 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 2, 2021Open, Classified

   Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.

   Z-2454-2021 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 97 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Break

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MY CUSTOMER HAS BEEN HAVING ISSUES WITH BIFUSE & TRIFUSE EXTENSION SETS. THEY ARE EXPERIENCING THAT THE DEVICE IS BREAKING WHEN IT IS CONNECTED/DISCONNECTED FROM THE IV TUBING. ADDITIONALLY, THE BLUE SEAL IS DROPPING AND REMAINS STUCK IN THE DOWN POSITION. THEY DO NOT HAVE LOT NUMBERS. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 01-04-2026 DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. PRODUCT WAS BROKEN AND NEEDED NEW PRODUCT. SLOWED THROUGHPUT IN THE UNIT. THEY ARE EXPERIENCING THAT THE DEVICE IS BREAKING WHEN IT IS CONNECTED/DISCONNECTED FROM THE IV TUBING. ADDITIONALLY THE BLUE SEAL IS DROPPING AND REMAINS STUCK IN THE DOWN POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020775 ↗
• MalfunctionNov 22, 2024Leak/Splash; Leak/Splash

  MATERIAL#: 20019E. BATCH#: 22125358. IT WAS REPORTED BY THE CUSTOMER THAT TRIFUSE WAS BROKEN FROM THE CONNECTOR SIDE AND BLOOD BACKED UP INTO THE UMBILICAL LINE, THAT WAS WHEN THE NURSE NOTICED THE BREAKAGE. VERBATIM: TRIFUSE WAS BROKEN FROM THE CONNECTOR SIDE AND BLOOD BACKED UP INTO THE UMBILICAL LINE, THAT WAS WHEN THE NURSE NOTICED THE BREAKAGE. ADDITIONAL INFO: 1. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. TRIFUSE WAS CONNECTED TO THE PATIENT AND THE BLOOD WAS BACKING UP INTO THE LINE. THIS EVENT ALSO RESULTED IN AN OPEN SYSTEM INCREASING THE POTENTIAL FOR LINE INFECTION. 2. CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? I DO NOT HAVE THE LOT # FOR THE TRIFUSE. THE LOT NUMBER FOR THE SMARTSITE EXTENSION THAT WAS MALFUNCTIONING TODAY IS (10) 22125358 REF: 20019E. 3. TOTAL NUMBER OF OCCURRENCES? TRIFUSE- 1, SMARTSITE EXTENSION- 2. 4. SAMPLE AVAILABLE IS MENTIONED AS YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? XXXXX. ADDITIONAL INFO: 1. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO A PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20758447 ↗
• MalfunctionNov 20, 2024Complete 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 FOR THE SMARTSITE EXTENSION ( BIFUSE) ONE PORT WILL FLUSH AND THE SECOND PORT IS OCCLUDED AND WILL NOT FLUSH. NURSES WERE SETTING UP FOR IV LINE PLACEMENT, BRAND NEW SET OUT OF PACKET AND PRIMING FOR LINE SET UP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20737694 ↗
• MalfunctionNov 20, 2024Complete 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. FOR THE SMARTSITE EXTENSION (BIFUSE) ONE PORT WILL FLUSH AND THE SECOND PORT IS OCCLUDED AND WILL NOT FLUSH. NURSES WERE SETTING UP FOR IV LINE PLACEMENT, BRAND NEW SET OUT OF PACKET AND PRIMING FOR LINE SET UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20737490 ↗
• MalfunctionNov 20, 2024Complete 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. FOR THE SMARTSITE EXTENSION (BIFUSE) ONE PORT WILL FLUSH AND THE SECOND PORT IS OCCLUDED AND WILL NOT FLUSH. NURSES WERE SETTING UP FOR IV LINE PLACEMENT, BRAND NEW SET OUT OF PACKET AND PRIMING FOR LINE SET UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20736761 ↗
• MalfunctionMar 4, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT BD SET XTN .4ML 9.5IN IV NDL FREE CONN SMALLBORE SPN M LL LINE OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSE ATTEMPTED TO FLUSH BOTH NEEDLELESS CONNECTOR PORTS. ONE SIDE FLUSHED AS IT SHOULD. THE OTHER SIDE WAS UNABLE TO BE FLUSHED, AS IF SOMETHING WAS OBSTRUCTING IT.

  Patient problems: Insufficient Information

  MAUDE report 18827873 ↗
• MalfunctionJun 20, 2023Material Separation; Material Separation

  IT WAS REPORTED WHILE USING BD SMARTSITE¿ EXTENSION SET PRESSURE RATED SMALLBORE BIFUSE COMPONENT SEPARATED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE A BROKEN MICROBORE EXTENSION SET THAT THAT WAS ON A PATIENT. THE PART IS: REF# (B)(4). IT LOOKS LIKE IT WAS A DEFECT WHERE IT SLIPPED RIGHT OUT OF THE NECK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17167591 ↗
• MalfunctionDec 23, 2022Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET Y-SITE DETACHED AND CAUSED IV FLUID TO LEAK OUT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "Y SITE BECAME DISCONNECTED DESPITE NOT BEING TOUCHED (AND SITE PARAFILM STILL INTACT) AND IV FLUIDS LEAKED OUT OF Y SITE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16043559 ↗
• MalfunctionDec 22, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD SMARTSITE¿ EXTENSION SET WAS CRYSTALIZING FLUID/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CRYSTALIZING FLUID/MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16040803 ↗
• MalfunctionSep 22, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED 80 Y EXT W/VLV PORTS & 2 SLD CLP HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONNECTOR SITE SHOULD BE ROUND AND CONNECT TO SYRINGES. THESE BATCHES ARE OF AN OVAL SHAPE AND THEREFORE WON'T CONNECT AND ALSO LEAK FLUID."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12512062 ↗
• MalfunctionSep 3, 2021Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED Y EXT W/VLV PORTS & 2 SLD CLP HAD KINKED TUBING AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLASTIC TUBING WAS DAMAGED PRIOR TO USE, THE TUBING APPEARS CRIMPED OR POSSIBLY MELTED AND THERE WAS A HOLE IN SO WHEN THE RN PLACED ON HER IV SITE AND TRIED TO DRAW FROM IT, BLOOD CAME OUT THE EXTENSION TUBING INSTEAD OF IN TO THE LAB TUBE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12425945 ↗
• MalfunctionAug 31, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED Y EXT W/VLV PORTS & 2 SLD CLP HAD BLOCKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ARE HAVING PROBLEMS WITH THE SMARTSITE EXTENSION SET REF (B)(4). WE HAVE HAD QUITE A FEW THAT WILL NOT FLUSH/PRIME."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12389651 ↗
• MalfunctionAug 18, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT Y EXT W/VLV PORTS & 2 SLD CLP HAD FLUSHING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THEY CONTINUE TO HAVE ISSUES WITH THE PRODUCT NOT FLUSHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12338146 ↗
• MalfunctionAug 9, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT 3 Y EXT W/VLV PORTS & 2 SLD CLP TUBING SETS WERE BLOCKED/OCCLUDED AND WOULD NOT PRIME OR FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SMARTSITE SKU 20019E NOT PRIMING OR FLUSHING. THIS IS THE THIRD INCIDENT THAT THEY ARE REPORTING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12294759 ↗
• MalfunctionJul 28, 2021Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT Y EXT W/VLV PORTS & 2 SLD CLP SETS HAD BLOCKAGE AND COULDN'T BE FLUSHED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I WAS ALERTED YESTERDAY BY OUR NM RN THAT SMARTSITE EXT SETS WERE NOT FLUSHING IT SEEMED TO BE ISOLATED TO LOT..."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12243088 ↗
• MalfunctionJul 21, 2021Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 13 Y EXT W/VLV PORTS & 2 SLD CLP WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER INDICATING SMARTSITE EXTENSION SET SKU 20019E IS FAILING TO PRIME AND FLUSH. NO ADVERSE RESULT TO PATIENT OR STAFF AS A RESULT OF THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12207114 ↗
• MalfunctionJun 23, 2021Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 1 Y EXT W/VLV PORTS & 2 SLD CLP EACH FROM LOTS 21016393, 21025279, AND 20126528 HAD FLOW ISSUES DURING USE. THIS OCCURRED ON 204 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER LEFT MESSAGE STATING THAT THE ISSUE WITH THE SMARTSITE NO FLUID CAN BE WITHDRAWN OR INJECTED IT LITERALLY LOCKS UP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12054887 ↗
• MalfunctionJun 23, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT 3 Y EXT W/VLV PORTS & 2 SLD CLP EXPERIENCED FLOW ISSUES AND WERE CLOGGED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "ONE OF THE BUNGS IS FAULTY, AS YOU CANNOT FLUSH, THERE IS NO MOVEMENT, I HAVE MARKED THE LINE WITH A BLACK MARKER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12054173 ↗
• MalfunctionJun 2, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT A Y EXT W/VLV PORTS & 2 SLD CLP HAD FLOW ISSUES AND WAS CLOGGED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "UNABLE TO DRAW BLOOD OR FLUSH".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11925728 ↗
• MalfunctionMay 20, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT 6 Y EXT W/VLV PORTS & 2 SLD CLP SETS WERE BLOCKED/OCCLUDED AND COULD NOT BE FLUSHED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SET DOESN'T ALLOW FLUSH TO BE PUSHED THROUGH THE Y EXTENSION SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11860612 ↗
• MalfunctionMar 29, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT 1 Y EXT W/VLV PORTS & 2 SLD CLP SET FROM LOT 20115015, 1 SET FROM LOT 20066231, AND 1 SET FROM AN UNSPECIFIED LOT HAD ISSUES WITH FLUID BLOCKAGE/FLOW ISSUES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD SEVERAL OF THESE SETS FAIL. THE PROBLEM IS THAT WE CAN'T FLUSH BOTH ENDS WITH OUT MANIPULATING THE VALVES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11586877 ↗
• MalfunctionMar 19, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT 1 Y EXT W/VLV PORTS & 2 SLD CLP SET FROM LOT 20125982, AND 1 SET FROM LOT 20115014 WERE BLOCKED DURING USE AND WOULDN'T FLUSH. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ALL REPORTS ARE CONCERNING ONE OR BOTH OF THE PORTS NOT FLUSHING. ONE REPORT THE PACKAGE WAS SEALED BUT EMPTY. THESE ISSUES ARE CONCERNING REF#20019E LOT NUMBERS REPORTED ARE #20125982 AND 20115014 (EXP DATE 2023/11/05) DATES OF REPORTS ARE FROM 1/29/2021 THROUGH 2/22/2021."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11528820 ↗
• MalfunctionMar 16, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT 1 Y EXT W/VLV PORTS & 2 SLD CLP SET FROM AN UNSPECIFIED LOT, 248 SETS FROM LOT 20125982, 1 SET FROM LOT 20095138, 6 SETS FROM LOT 20115020, 4 SETS FROM LOT 20066717, 3 SETS FROM LOT 20115014, AND 123 SETS FROM LOT 20115023 WOULD NOT FLUSH DUE TO FLOW ISSUES/BLOCKAGE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAD ANOTHER FAILURE TODAY OF A SMART SITE THAT WOULD NOT FLUSH. I MOST INSTANCES, STAFF CO AIDED THEM CONTAMINATED AND DO NOT KEEP THEM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11492219 ↗
• MalfunctionMar 7, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED 2 Y EXT W/VLV PORTS & 2 SLD CLP SETS HAD DEFECTIVE PORTS THAT BLOCKED FLUID FROM FLOWING THROUGH. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ATTEMPTED TO USE TWO DIFFERENT SMARTSITE EXTENSION SETS. BOTH HAD DEFECTIVE PORT. LOT #(10) 20115023".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11429607 ↗
• MalfunctionFeb 5, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT 6 Y EXT W/VLV PORTS & 2 SLD CLP CLOGGED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL RERPORTER: "IT WAS REPORTED THE SET WILL NOT FLUSH. VERBATIM: SAME ONGOING ISSUE WITH THIS SET; ONE LEG WILL NOT FLUSH. HOSPITAL HAS SIX SETS TO RETURN. FAILURE DATES REPORTED AS "COLLECTED OVER THE PAST FEW WEEKS." NO PATIENT HARM AS THE FAILURE WAS FOUND DURING PRIMING. PLEASE DO NOT CONTACT ANYONE AT (B)(6)."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11285829 ↗