Alaris, SmartSite 0.0022003Recalls & reported problems

Summary

The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 10885403242045), received between Aug 10, 2018 and May 12, 2026 — classified as 88 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (61 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 88 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Complete Blockage

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY THE CUSTOMER THAT WHEN CONNECTING A SALINE SYRINGE TO THE EXTENSION SET OR PREPARING AN IV LINE, THE SYRINGE MUST BE DETACHED AND REATTACHED IN ORDER FOR THE LINE TO FLUSH PROPERLY. THE SAME ISSUE OCCURS WHEN ATTEMPTING TO DRAW BLOOD. DURING IV INITIATION, SOME UNITS DID NOT INITIALLY ALLOW BLOOD RETURN WHEN USING A VACUTAINER, REQUIRING THE CUSTOMER TO ATTACH AN EMPTY SYRINGE TO MANUALLY PULL BLOOD FROM THE LINE. THE CUSTOMER PURCHASED THREE CASES CONTAINING 100 UNITS EACH. THEY STATED THAT APPROXIMATELY FIVE UNITS FROM ONE OF THE CASES PRESENTED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25153063 ↗
• MalfunctionJan 9, 2026Obstruction of Flow

  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 THE CUSTOMER THAT THIS SET FOR THE EMERGENCY DEPARTMENT THAT IS DEFECTIVE AND WILL NOT WORK TO DRAW BLOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24026478 ↗
• MalfunctionJan 9, 2026Obstruction of Flow

  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 THE CUSTOMER THAT THIS SET FOR THE EMERGENCY DEPARTMENT THAT IS DEFECTIVE AND WILL NOT WORK TO DRAW BLOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24026463 ↗
• MalfunctionJan 9, 2026Obstruction of Flow

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATRIM. IT WAS REPORTED BY THE CUSTOMER THAT THIS SET FOR THE EMERGENCY DEPARTMENT THAT IS DEFECTIVE AND WILL NOT WORK TO DRAW BLOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24026393 ↗
• MalfunctionDec 1, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET HAD CONNECTION ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT WHEN THEY ARE ATTACHING OUR TUBING FOR OUR PET SCANS, WE ARE MEETING RESISTANCE IMMEDIATELY AT THE SMARTSITE NEEDLE-FREE CONNECTOR. IT ALSO OCCASIONALLY OCCURS WHILE WE ARE PRIMING THE EXTENSION SET BEFORE ATTACHING TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23688978 ↗
• MalfunctionDec 1, 2025Obstruction of Flow; Connection Problem; Obstruction of Flow; Connection Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET HAD CONNECTION ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT WHEN THEY ARE ATTACHING OUR TUBING FOR OUR PET SCANS, WE ARE MEETING RESISTANCE IMMEDIATELY AT THE SMARTSITE NEEDLE-FREE CONNECTOR. IT ALSO OCCASIONALLY OCCURS WHILE WE ARE PRIMING THE EXTENSION SET BEFORE ATTACHING TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23688976 ↗
• MalfunctionMar 21, 2025Failure to Infuse; Failure to Infuse

  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 COULDN¿T GET THE FLUID TO PRIME THROUGH IT.¿ SHE DISCARDED THE TUBING INTO THE GARBAGE AND OBTAINED ANOTHER TUBING. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21667652 ↗
• MalfunctionSep 14, 2023Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION MAT#: 22003E-07 ,LOT#: 23065504. IT WAS REPORTED BY CUSTOMER THAT BD SMARTSITE EXTENSION SET NEEDLE-FREE VALVE (REF# (B)(4)) ARE NOT "ACTIVATING " WHEN A SALINE FLUSH IS ATTACHED OR BLOOD DRAW IS ATTEMPTED. VERBATIM: RCC RECEIVED COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. MEDLINE REFERENCE: (B)(4). ITEM: 22003E-07. QUANTITY AFFECTED: (B)(4). SERIAL/LOT NUMBER: (B)(6). PO #: (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE PER CUSTOMER: THE CUSTOMER REPORTED THAT ADAPTORS (REF( B)(4)) AND BD SMARTSITE EXTENSION SET NEEDLE-FREE VALVE (REF (B)(4)) ARE NOT "ACTIVATING " WHEN A SALINE FLUSH IS ATTACHED OR BLOOD DRAW IS ATTEMPTED. CUSTOMER DISPOSITION REQUEST: REPLACEMENT. TUE 09/05/2023 9:28 AM I AM FOLLOWING UP FROM A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. PLEASE RESPOND ACCORDINGLY WITH THE RMA NUMBER, IF NECESSARY, AND THE DISPOSITION OF THE CONCERN. PLEASE CONTACT THE CUSTOMER AND CC ME ON ANY FUTURE COMMUNICATION.

  Patient problems: Insufficient Information

  MAUDE report 17746270 ↗
• MalfunctionSep 14, 2023Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION WAS PROVIDED. MAT#: 22003E-07 BATCH#: 22119142 IT WAS REPORTED BY CUSTOMER THAT NOT ACTIVATING WHEN SALINE FLUSH IS ATTACHED OR BLOOD DRAW IS ATTEMPTED. VERBATIM: RCC RECEIVED THE COMPLAINT VIA EMAIL. EMAIL AS ATTACHED NOT ACTIVATING WHEN A SALINE FLUSH IS ATTACHED OR BLOOD DRAW IS ATTEMPTED. INJURIES OR ADVERSE EVENT: NO ITEM: 22003E-07 QUANTITY AFFECTED: 4 CASES SERIAL/LOT NUMBER: (B)(6). PO : (B)(6). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES 15SEP2023 - DATE OF EVENT: FIRST INCIDENT OCCURRED ON (B)(6) 2023, SECOND INCIDENT OCCURRED ON (B)(6) 2023 - ARE YOU ABLE TO DESCRIBE WHAT IS ¿NOT ACTIVATING¿ IN DETAIL? ON TWO DIFFERENT PRODUCTS REF#2000E NEEDLE-FREE VALVE AND REF#22003E-07 EXTENSION SET NEEDLE-FREE VALVE, THE BLUE CHAMBER THAT ALLOWS FLUID TO FLOW THROUGH THE VALVE WAS NOT COMPRESSING/ACTIVATING, PREVENTING FLUID (SALINE FLUSH OR BLOOD DRAW) FROM FLOWING THROUGH IT. - WAS THERE ANY PATIENT INVOLVEMENT? YES - ANY ADVERSE EVENTS OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO REPORTED INJURIES, HEALTHCARE PROFESSIONALS REMOVED DEFECTED PRODUCTS, OPENED NEW PRODUCTS UNTIL THEY FOUND ONE THAT WORKED. - WHAT WAS THE PATIENT OUTCOME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17746207 ↗
• MalfunctionJan 9, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 5 OF THE BD IV EXTENSION SET ALARIS® SMARTSITE WERE UNABLE TO FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNABLE TO FLUSH EXTENSION TUBINGS WITH 10 ML 0.9% NORMAL SALINE PRE-FILLED SYRINGES. THE LOT NUMBERS OF 2 EXTENSION TUBING'S THAT FLUSHED WERE DIFFERENT THAN THE 5-EXTENSION TUBING WITH THE SAME LOT NUMBERS (22039352), THAT DID NOT FLUSH. THIS HAS HAPPENED WITH 1 OR 2 EXTENSIONS TUBING HERE AND THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16126701 ↗
• MalfunctionJan 4, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED WHILE USING BD ALARIS SMARTSITE EXTENSION SET THERE WAS A BLOCKAGE. THIS OCCURRED 7 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE PRODUCT IS NOT WORKING CORRECTLY AND/OR FUNCTIONING PROPERLY. WE HAD A TOTAL OF 7 JUST THIS PAST WEEK THAT THE SAME THING HAPPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16097434 ↗
• MalfunctionDec 5, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 10 BD ALARIS¿ SMARTSITE¿ EXTENSION SETS WERE BLOCKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE HAD A DEPARTMENT STATING THAT THE SMARTSITES ARE NOT WORKING CORRECTLY AND THE LAST 10 OR SO THEY HAVE USED HAVE NOT BEEN FUNCTIONING PROPERLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15921232 ↗
• MalfunctionOct 13, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD SMARTSITE¿ EXTENSION SET EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: QUALITY ISSUE WITH LEAKING AROUND THE END THAT HAS THE BLUE ON IT.

  Patient problems: Insufficient Information

  MAUDE report 15601435 ↗
• MalfunctionSep 13, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE BD SMARTSITE¿ EXTENSION SET, 1 SMARTSITE¿ NEEDLE-FREE CONNECTOR IS DIFFICULT TO ATTACH THE SALINE FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I ALSO FOUND IT DIFFICULT TO ATTACH AND IT REQUIRED MUCH MORE THAN USUAL FORCE TO ATTACH THE SALINE FLUSH AND QUITE A BIT OF PRESSURE TO GET THE FLUSH TO GO THROUGH, WHICH THEN CAME OUT THE END AND SHOWERED MY TOP WITH SALINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15415358 ↗
• MalfunctionJul 28, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET WOULD NOT PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE EXTENSION SET WOULD NOT PRIME/FLUSH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15126925 ↗
• MalfunctionJul 28, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET WOULD NOT PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE EXTENSION SET WOULD NOT PRIME/FLUSH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15126913 ↗
• MalfunctionJun 16, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET EXPERIENCED OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EXTENSION SET WILL NOT FLUSH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14721572 ↗
• MalfunctionMay 11, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT AT LEAST ONE BD ALARIS SMARTSITE EXTENSION SET WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE'VE HAD SEVERAL FAILED EXTENSION SETS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14365332 ↗
• MalfunctionMay 10, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT HAS BEEN BROUGHT TO OUR ATTENTION BY NURSING THAT THEY ARE HAVING TROUBLE WITH THE ITEM NOT FUNCTIONING/FLUSHING PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14346773 ↗
• MalfunctionMay 9, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 4-5 BD ALARIS SMARTSITE EXTENSION SET EXPERIENCED OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSES ARE HAVING TROUBLE PRIMING THE EXTENSION SET. SOMETIMES THEY CAN PUSH AND PULL AND IT WORKS. I HAVE 4 EXTENSION SETS THAT HAVE STAFF HAVE HAD AN ISSUE WITH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14342200 ↗
• MalfunctionMay 6, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 37 BD ALARIS SMARTSITE EXTENSION SETS WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE SALINE WOULD NOT FLUSH THROUGH THE SETS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14309409 ↗
• MalfunctionApr 28, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET EXPERIENCED NO BLOOD RETURN AND INABILITY TO FLUSH THE EXTENSION SET. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHE REPORTED THAT THEY ARE EXPERIENCING NO BLOOD RETURN AND UNABLE TO FLUSH THIS EXTENSION SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14245551 ↗
• MalfunctionApr 21, 2022Flushing Problem; Flushing Problem

  IT WAS REPORTED THAT THERE ARE 159 BD ALARIS SMARTSITE EXTENSION SET THAT EXPERIENCED FLUSHING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FLUSHING ISSUES; SMARTSITE NOT OPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14166725 ↗
• MalfunctionApr 19, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR EXPERIENCED DEFECTIVE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EXTENSION SET TUBING SEVERELY KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14142896 ↗
• MalfunctionApr 15, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 132 BD ALARIS¿ SMARTSITE¿ EXTENSION SETS FROM LOT 21119803, 19 SETS FROM LOT 21119800, 1 SET FROM LOT 21129217, AND 48 SETS FROM AN UNSPECIFIED LOT WERE BLOCKED DURING THE FLUSHING PROCESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THEY ARE NOT FLUSHING AND WE ARE CONSTANTLY RUNNING TO FIND A NEW ONE AND HOPING IT WORKS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14121614 ↗