Alaris, SmartSite 0.00421Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885403220609), received between Oct 24, 2022 and Jan 7, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Disconnection

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A BRIEF DESCRIPTION OF THE ISSUE(S) ENCOUNTERED WITH MATERIAL #42100E-07. TUBING DISCONNECTS EVEN AFTER TIGHTENING. THE LOT NUMBER(S) ASSOCIATED WITH THE REPORTED ISSUE. UNABLE TO OBTAIN, PACKAGING HAD ALREADY BEEN DISCARDED IN PRE-OP, THE ISSUE OCCURRED IN THE OPERATING ROOM. ANY PATIENT HARM, INJURY, COMPLICATION, OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT(S). 1. BLOOD LOSS-BOTH OCCURRENCES, 2. PT WOKE UP-11/4-OCCURRENCE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23998785 ↗
• MalfunctionJan 7, 2026Disconnection

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A BRIEF DESCRIPTION OF THE ISSUE(S) ENCOUNTERED WITH MATERIAL #42100E-07. TUBING DISCONNECTS EVEN AFTER TIGHTENING. THE LOT NUMBER(S) ASSOCIATED WITH THE REPORTED ISSUE. UNABLE TO OBTAIN, PACKAGING HAD ALREADY BEEN DISCARDED IN PRE-OP, THE ISSUE OCCURRED IN THE OR. ANY PATIENT HARM, INJURY, COMPLICATION, OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT(S). 1. BLOOD LOSS-BOTH OCCURRENCES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23998782 ↗
• MalfunctionOct 22, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING. IT WAS REPORTED BY THE CUSTOMER THAT IS DEFECTIVE AND WOULDN¿T FLOW THE FLUID. IT WENT IN THE DRIP CHAMBER BUT WOULDN¿T FLOW DOWN THE REST OF THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23364254 ↗
• MalfunctionOct 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY THE CUSTOMER THAT THE TUBING CONNECTION THAT COMES PRECONNECTED CAME APART AND THE PATIENT BLOOD BACKED UP AND LEAKED ONTO THE FLOOR. PTS IV TUBING CAME APART AT THE CONNECTOR CAUSING BLEEDING ONTO PT/BED. INFECTION/BLEEDING RISK. TUBING CAME DISCONNECTED WHEN ATTACHING IV TUBING TO PATIENTS IV DESPITE TIGHTENING CONNECTION PORTS WHEN PRIMING IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517868 ↗
• MalfunctionOct 23, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET HAD BLOOD LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY THE CUSTOMER THAT THE TUBING CONNECTION THAT COMES PRECONNECTED CAME APART AND THE PATIENT BLOOD BACKED UP AND LEAKED ONTO THE FLOOR. PTS IV TUBING CAME APART AT THE CONNECTOR CAUSING BLEEDING ONTO PT/BED. INFECTION/BLEEDING RISK. TUBING CAME DISCONNECTED WHEN ATTACHING IV TUBING TO PATIENTS IV DESPITE TIGHTENING CONNECTION PORTS WHEN PRIMING IT.

  Patient problems: Exposure to Body Fluids

  MAUDE report 20516096 ↗
• MalfunctionOct 8, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20393063 ↗
• MalfunctionOct 13, 2023Material Separation; Material Separation

  NO ADDITIONAL INFORMATION: MATERIAL#: 42100E-07 BATCH#: UNKNOWN IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD PROBLEMS WITH THE CONNECTIONS COMING LOOSE, SOMETIMES FALLING TO THE FLOOR. THIS RESULTS IN CONTAMINATING THE TUBING AND BLOOD COMING BACK. VERBATIM: DETAILS OF INQUIRY: HELLO, ON OUR UNIT WE USE THE BD SMARTSITE GRAVITY SET DAILY FOR PATIENT IV FLUIDS. MULTIPLE TIMES WE HAVE HAD PROBLEMS WITH THE CONNECTIONS COMING LOOSE, SOMETIMES FALLING TO THE FLOOR. THIS RESULTS IN CONTAMINATING THE TUBING AND BLOOD COMING BACK AND RESPONSE RECEIVED ON 04-OCT-2023. THANK YOU AGAIN FOR LETTING ME KNOW ABOUT THIS. I DO HAVE A QUESTION, IF YOU WOULDN¿T MIND. I PUT A PICTURE OF THE 42100E-07 SET ON THE WORD DOCUMENT. COULD YOU PLEASE LET ME KNOW IF THE SET WAS COMING APART AT THE AREA WHERE THE ARROWS ARE OR WAS IT SOMEWHERE ELSE? ALSO, I¿M CURIOUS IF YOU KNOW IF THE END USER IS ACTIVELY TIGHTENING THE STOPCOCK SEGMENT ON BOTH ENDS ONCE THEY TAKE IT OUT OF THE PACKAGE? ALTHOUGH IT¿S CONNECTED IN THE PACKAGE, IT IS NOT BONDED AND CAN COME LOOSE DURING SHIPPING. THE DFU REMINDS THEM TO TIGHTEN THOSE CONNECTIONS BEFORE USE. I¿M NOT SUGGESTING THAT IS WHAT IS HAPPENING, I¿M JUST COVERING ALL A

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17931064 ↗
• MalfunctionOct 12, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING UNSPECIFIED BD EXTENSION SET THE CONNECTION CAME APART AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ISSUE REPORTED BY RN. MANY TIMES THEY HAVE A PROBLEM WITH THE CONNECTIONS COMING LOOSE, FALLING TO THE FLOOR AND RESULTING IN CONTAMINATION OF THE TUBING AND BLOOD COMING BACKWARDS AND POURING OUT OF THE IV. THE NURSES IN THEIR UNIT, INCLUDING HER HAVE NOTICED THIS FOR AS LONG AS THEY HAVE BEEN USING IT AND SHE HAS BEEN THERE FOR 6 YEARS. SHE IS NOT SURE IF THE ISSUES PRIOR HAVE BEEN REPORTED AND STATES THAT IT SEEMS TO BE AN ISSUE WITH HOW THE PRODUCT IS MANUFACTURED. THE CONNECTION IS EITHER LOOSE RIGHT OUT OF THE PACKAGE OR BECOMES LOOSE VERY EASILY WHERE THE TUBING CONNECTS AT THE SITE OF THE VALVES. UNSURE IF THEY HAVE THE EXACT PRODUCT USED TO RETURN FOR EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 17927854 ↗
• MalfunctionMar 17, 2023Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED WHILE USING BD ALARIS SMARTSITE GRAVITY SET THE PRODUCT WAS MISASSEMBLED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SOME SETS HAVE THE CHECK VALVE (ONE-WAY VALVE) UPSIDE DOWN. WE FOUND SETS WITH THE CLEAR SIDE UP AND WHITE PIECE FACING DOWN, BLOCKING THE FLOW OF FLUID. OTHERS WERE MANUFACTURED CORRECTLY WITH THE WHITE PART FACING UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16566955 ↗
• MalfunctionOct 24, 2022Component Missing; Component Missing

  IT WAS REPORTED BY THE CUSTOMER THAT THE BD IV GRAVITY AND SECONDARY SETS WERE MISSING 2 CAPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE NOTICED A LOT OF PN 42100E-07 IS MISSING 2 CAPS ON THE STOPCOCKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15663919 ↗