Alaris, SmartSite 20159ERecalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 07613203012270), received between Apr 17, 2019 and Jul 14, 2025 — classified as 69 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (58 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 69 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE MAIN LINE FLUSHES, BUT THE Y PART IS EXTREMELY DIFFICULT TO FLUSH, REQUIRES IMMENSE PRESSURE/FORCE & THEY OFTEN HAVE TO REMOVE THE EXTENSION AND OBTAIN A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494173 ↗
• MalfunctionFeb 13, 2024Leak/Splash; Material Separation; Leak/Splash; Material Separation

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18697167 ↗
• MalfunctionOct 2, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD SMARTSITE¿ EXTENSION SETS ARE BLOCKED. THE FOLLOWING WAS RECEIVED FROM THE ORIGINAL REPORTER. WE ARE HAVING ISSUES WITH AN EXTENSION SET FORM ALARIS. NURSING STAFF HAVE ADVISED ME THAT THEY ARE HAVING DIFFICULTY WITH "FLUSHING" OUT DUE TO THE WHITE RUBBER PORTION CONNECTOR. XXX IS CC'D TO PROVIDE BETTER INSIGHT IF NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17857821 ↗
• MalfunctionMay 31, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2071-PC UNABLE TO FLUSH OR DRAW BLOOD FROM BD SMARTSITE EXTENSION SETS. THE VALVE IS INCONSISTENTLY NOT PATENT; IT IS OFTEN THE SIDE PORT AS OPPOSED TO THE MAIN PORT. NURSES ARE ATTEMPTING TO FLUSH PRIOR TO STARTING IV START, NOT ALWAYS ABLE TO WHICH RESULTS IN HAVING TO OPEN ANOTHER PACKAGE OR ONLY HAVE ONE LUMEN AVAILABLE TO USE WHICH DEFEATS THE PURPOSE OF THE TWO-PORT EXTENSION SETS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17035633 ↗
• MalfunctionMar 2, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT DURING USE WITH AN UNSPECIFIED AMOUNT OF BD ALARIS¿ SMARTSITE¿ EXTENSION SET THE PORTS ARE OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE PORTS WILL NOT FLUSH OR DRAW BLOOD, IT IS OCCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475476 ↗
• MalfunctionMar 2, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT DURING USE WITH BD ALARIS¿ SMARTSITE¿ EXTENSION SET ONE OF THE PORTS WAS OCCLUDED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN STARTING AN IV WITH THIS EXTENSION SET, ONE PORT WILL FLUSH WITHOUT DIFFICULTY AND THE OTHER PORT WILL NOT FLUSH AT ALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475474 ↗
• MalfunctionJan 10, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED WHILE USING BD ALARIS SMARTSITE EXTENSION Y SET THE SET DID NOT FLOW CORRECTLY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: Y SETS NOT FLUSHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16132078 ↗
• MalfunctionDec 16, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED WHILE USING BD ALARIS SMARTSITE EXTENSION SET THE TUBING WOULD NOT PRIME PROPERLY THREE TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TODAY, WE HAD THREE MORE INSTANCES WHERE THE TUBING WOULD NOT PRIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15995043 ↗
• MalfunctionOct 24, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 6 BD ALARIS SMARTSITE EXTENSION SETS WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNABLE TO FLUSH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15658100 ↗
• MalfunctionOct 19, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 3 BD ALARIS SMARTSITE EXTENSION SET EXPERIENCED OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LAST WEEK I REACHED OUT TO CUSTOMER SERVICE ABOUT ITEM #(B)(4) THAT WAS NOT FLUSHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15633084 ↗
• MalfunctionOct 11, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE 85 BD ALARIS SMARTSITE EXTENSION SET EXPERIENCED OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EXTENSION SET NOT FLUSHING; FEELS OCCLUDED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15583849 ↗
• MalfunctionOct 6, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD EXT SET W/MACROBORE 2VPS Y-CONN LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CT DEPARTMENT DID A 3CC/SEC INJECTION AND CONTRAST LEAKED FROM THE TUBING SET. PATIENT WAS NOT HARMED WITH THE INJECTION, ONLY HAD A SMALLAMOUNT OF CONTRAST ON CLOTHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15556362 ↗
• MalfunctionSep 28, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 3 BD SMARTSITE¿ EXTENSION SET EXPERIENCED BLOCKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NOT ALLOWING FOR FLUID FLUSHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15499227 ↗
• MalfunctionSep 16, 2022Complete Blockage; Obstruction of Flow; Air/Gas in Device; Complete Blockage; Obstruction of Flow; Air/Gas in Device

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET HAD A LARGE AIR BUBBLE IN THE TUBING. ADDITIONALLY, THE LINE WAS DIFFICULT TO PRIME DUE TO BLOCKAGE, ACCUMULATING BLOOD IN THE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A LARGE AIR BUBBLE STAYS IN THE TUBING.  ALSO TO PRIME IT YOU NEED TO PUSH EXTREMELY HARD ON THE BLUE VALVE INSIDE THE TUBING AND DISCONNECT AND RECONNECT TO THE OTHER SIDE TO FULLY FILL THE TUBING, THIS INCREASES CONTAMINATION POTENTIAL. THE SECOND ISSUE IS IT ACCUMULATES BLOOD IN THE TUBING AND CAUSE A LONG BLOOD CLOT.  I DO NOT FEEL COMFORTABLE FLUSHING THE TUBING WITH THE BLOOD INSIDE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15442625 ↗
• MalfunctionSep 15, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD EXT SET W/MACROBORE 2VPS Y-CONN LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE BLUE PLUG WITHIN THE CATHETER LEAKS AT TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432525 ↗
• MalfunctionSep 15, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED WHILE USING BD EXT SET W/MACROBORE 2VPS Y-CONN THERE WERE FLOW ISSUES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: -THE NEW EXTENSION SETS ARE EXTREMLY HARD TO FLUSH. OFTEN I AM CALLED INTO ROOMS TO HELP FLUSH THE EXTENSION SET DUE TO DIFFICULTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432523 ↗
• MalfunctionSep 15, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD EXT SET W/MACROBORE 2VPS Y-CONN LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF THE PORTS WAS LEAKY AND HAD TO BE CLAMPED SHUT TO PREVENT BACK FLOW OF BLOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432400 ↗
• MalfunctionAug 8, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 3 BD SMARTSITE¿ EXTENSION SETS EXPERIENCED BLOCKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR BD SMARTSITE EXTENSION SET WITH 2 NEEDLE-FREE VALVES HAVE BEEN HAVING ISSUES. ONE OF THE SITES WILL NOT FLUSH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15183249 ↗
• MalfunctionJul 26, 2022Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT 5 BD ALARIS SMARTSITE EXTENSION SETS FROM LOT 22039080, 1 SET FROM LOT 21119807, AND 3 SETS FROM LOT 22029775 EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATED THE DEVICE IS NOT LETTING FLUID FLOW PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108299 ↗
• MalfunctionJul 19, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD SMARTSITE¿ EXTENSION SET EXPERIENCED BLOCKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I REACHED OUT TO CUSTOMER SERVICE ABOUT ITEM #20159E THAT WAS NOT FLUSHING. THERE ARE TWO LOT NUMBERS THAT CLINICAL STAFF HAS IDENTIFIED AS HAVING THIS ISSUE WITH MULTIPLE ITEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15055502 ↗
• MalfunctionJul 18, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD SMARTSITE¿ EXTENSION SET EXPERIENCED BLOCKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I REACHED OUT TO CUSTOMER SERVICE ABOUT ITEM #20159E THAT WAS NOT FLUSHING. THERE ARE TWO LOT NUMBERS THAT CLINICAL STAFF HAS IDENTIFIED AS HAVING THIS ISSUE WITH MULTIPLE ITEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15047879 ↗
• MalfunctionJul 18, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD SMARTSITE¿ EXTENSION SET EXPERIENCED BLOCKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I REACHED OUT TO CUSTOMER SERVICE ABOUT ITEM #: 20159E THAT WAS NOT FLUSHING. THERE ARE TWO LOT NUMBERS THAT CLINICAL STAFF HAS IDENTIFIED AS HAVING THIS ISSUE WITH MULTIPLE ITEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15047835 ↗
• MalfunctionJul 13, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD SMARTSITE¿ EXTENSION SET EXPERIENCED BLOCKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I REACHED OUT TO CUSTOMER SERVICE ABOUT ITEM #20159E THAT WAS NOT FLUSHING. THERE ARE TWO LOT NUMBERS THAT CLINICAL STAFF HAS IDENTIFIED AS HAVING THIS ISSUE WITH MULTIPLE ITEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15005259 ↗
• MalfunctionJun 16, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT TWO BD ALARIS SMARTSITE EXTENSION SET WERE DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE PRODUCT ARE DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14718024 ↗
• MalfunctionMay 10, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED WHILE USING BD ALARIS SMARTSITE¿ EXTENSION SET, BIFUSE 2 SMARTSITE¿ NEEDLE-FREE CONNECTOR THE NEEDLE WAS CLOGGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE ARE ISSUES FLUSHING MEDS THROUGH THE EXTENSION SETS. THEY HAVE ISSUES FLUSHING MEDS THROUGH THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14349170 ↗