Alaris, SmartSite 47177ERecalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 10885403235436), received between Jul 9, 2020 and Jul 6, 2026 — classified as 1 injury, 64 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (19 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 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2026Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25727174 ↗
• MalfunctionJun 18, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKING FROM WHERE THE TUBING ENTERS INTO A HUB AND TUBING KINKS FAIRLY EASY AS COMPARED TO PREVIOUS STOCK." ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: WHAT WAS THE MEDICATION/FLUID IN USE AT THE TIME OF THE EVENT? NORMAL SALINE DESCRIBE ANY PATIENT¿S HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. DID NOT REACH ANY PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25555230 ↗
• MalfunctionJun 18, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKING FROM WHERE THE TUBING ENTERS INTO A HUB AND TUBING KINKS FAIRLY EASY AS COMPARED TO PREVIOUS STOCK." ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: WHAT WAS THE MEDICATION/FLUID IN USE AT THE TIME OF THE EVENT? NORMAL SALINE. DESCRIBE ANY PATIENT¿S HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. DID NOT REACH ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25555229 ↗
• MalfunctionJun 18, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKING FROM WHERE THE TUBING ENTERS INTO A HUB AND TUBING KINKS FAIRLY EASY AS COMPARED TO PREVIOUS STOCK." ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: WHAT WAS THE MEDICATION/FLUID IN USE AT THE TIME OF THE EVENT? NORMAL SALINE. DESCRIBE ANY PATIENT¿S HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. DID NOT REACH ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25555227 ↗
• MalfunctionJun 18, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKING FROM WHERE THE TUBING ENTERS INTO A HUB AND TUBING KINKS FAIRLY EASY AS COMPARED TO PREVIOUS STOCK." ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: WHAT WAS THE MEDICATION/FLUID IN USE AT THE TIME OF THE EVENT? NORMAL SALINE DESCRIBE ANY PATIENT¿S HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. DID NOT REACH ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25555225 ↗
• MalfunctionJun 12, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GRAVITY SET 47177E, ISSUES IN RADIOLOGY WITH LEAKING AT DISTAL END OF FIXED COLLAR WHEN CONNECTING TO MATING COMPONENT (CATHETER ADAPTOR). ISSUE MAY BE DUE TO OPENING VENT WHEN FILLING DRIP CHAMBER WITH GLASS BOTTLE. THEY HAD A MATING ISSUE ALSO WITH A SPECIALIZED CATHETER/FOLEY DEVICE IN CYSTO, WHICH RESULTED IN THEM HAVING TO CANCEL THE CASE. WE DO NOT HAVE A SAMPLE OF THE FOLEY, ISSUE WAS ALSO LEAKING AT DISTAL END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25494385 ↗
• MalfunctionJun 11, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE GETTING COMPLAINTS ABOUT LEAKAGE WITH THE NEW GRAVITY KITS AND WOULD LIKE TO SWITCH BACK TO THE OLD KITS WE USED. THE NEW GRAVITY KIT NUMBER 7151, REF# 47177E ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: KINDLY PROVIDE THE BATCH/LOT NUMBER OF THE PRODUCT. UNKNOWN DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. UNABLE TO COMPLETE PATIENT EXAM DUE TO LEAKAGE FROM GRAVITY SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25474089 ↗
• MalfunctionMay 20, 2026Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET HAD CONNECTION ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT THE PRIMARY TUBING IS NOT MAKING A COMPLETE SEAL AT THE NEEDLE CATHETER HUB AND ALLOWING THE NORMAL SALINE TO LEAK OUT AND NOT FLOW INTO THE CLIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233402 ↗
• MalfunctionMay 20, 2026Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET HAD CONNECTION ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT THE PRIMARY TUBING IS NOT MAKING A COMPLETE SEAL AT THE NEEDLE CATHETER HUB AND ALLOWING THE NORMAL SALINE TO LEAK OUT AND NOT FLOW INTO THE CLIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233395 ↗
• MalfunctionMay 20, 2026Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT THE PRIMARY TUBING IS NOT MAKING A COMPLETE SEAL AT THE NEEDLE CATHETER HUB AND ALLOWING THE NORMAL SALINE TO LEAK OUT AND NOT FLOW INTO THE CLIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233393 ↗
• MalfunctionMay 20, 2026Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT THE PRIMARY TUBING IS NOT MAKING A COMPLETE SEAL AT THE NEEDLE CATHETER HUB AND ALLOWING THE NORMAL SALINE TO LEAK OUT AND NOT FLOW INTO THE CLIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233392 ↗
• MalfunctionMay 20, 2026Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET HAD CONNECTION ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT THE PRIMARY TUBING IS NOT MAKING A COMPLETE SEAL AT THE NEEDLE CATHETER HUB AND ALLOWING THE NORMAL SALINE TO LEAK OUT AND NOT FLOW INTO THE CLIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233390 ↗
• MalfunctionMay 20, 2026Leak/Splash; Connection Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233386 ↗
• MalfunctionApr 22, 2026Fluid/Blood Leak; Connection Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET HAS CONNECTION ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT THE PRIMARY TUBING HAS ISSUES CONNECTING AND THREADING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958746 ↗
• MalfunctionApr 22, 2026Fluid/Blood Leak; Connection Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET HAS CONNECTION ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT THE PRIMARY TUBING HAS ISSUES CONNECTING AND THREADING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958745 ↗
• MalfunctionJan 6, 2026Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT ORIGINAL TUBING CONTINUES TO BE DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977200 ↗
• MalfunctionDec 16, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT EXPERIENCED DIFFICULTY ADMINISTERING IV MEDICATION THROUGH THE DISTAL SMARSITE PORT OF THE IV AND IT IS STILL DEFINITELY HAPPENING WITH SOME TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822553 ↗
• MalfunctionApr 30, 2025Leak/Splash; Leak/Splash

  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 CUSTOMER THAT THE IV LINE WAS FOUND BROKEN APART. IT WAS A CLEAN LINE ABOVE THE SECOND OR 3RD PORT FROM THE PATIENT CATHETER SITE. BLOOD HAD FLOWED UP FROM PT HAND IV SITE AND WAS DRIPPING OUT OF THE IV, WHILE THE IV BAG WAS RUNNING INTO THE PT BED AND LR [LACTATED RINGERS] WAS GETTING THE BLANKET AND SIDE OF GOWN WET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937908 ↗
• MalfunctionApr 30, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE IV LINE WILL PRIME, BUT WHEN CONNECTED TO PT'S IV IT WILL NOT CONTINUE TO RUN BY GRAVITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21936894 ↗
• MalfunctionMar 25, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. MY PROBLEM WITH THE BD TUBING IS THE RIGIDITY - I'VE HEARD BOTH (B)(6) AND (B)(6) (THESE ARE ANESTHETISTS THAT START IV¿S IN OUR OFFICE) COMPLAIN ABOUT THIS AS WELL. IT CAN BE DIFFICULT TO ATTACH TO THE ANGIO, IT SOMETIMES COMES LOOSE (CAUSING A LEAK), AND SOMETIMES EVEN STARTS TO PULL THE IV OUT. ADDITIONAL INFORMATION RECEIVED ON 14MAR: BEFORE USE ON A PATIENT WHILE PRIMING THE TUBING. NONE, AS THE PROBLEM WAS DISCOVERED BEFORE IT WAS ATTACHED TO THE PT. IV FLUID LEAKED OUT ONTO THE FLOOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21694487 ↗
• MalfunctionMar 25, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. WE HAVE HAD SOME MORE IV LINES DISCONNECT AT THE SAME JUNCTION THAT IT HAPPENED AT BEFORE. I HAVE THREE TUBINGS IN THE OFFICE TO SEND TO YOU. ONE WAS ALREADY ATTACHED TO THE PATIENT WHEN IT DISCONNECTED. MY PROBLEM WITH THE BD TUBING IS THE RIGIDITY - I'VE HEARD BOTH *** AND H*** (THESE ARE ANESTHETISTS THAT START IV¿S IN OUR OFFICE) COMPLAIN ABOUT THIS AS WELL. IT CAN BE DIFFICULT TO ATTACH TO THE ANGIO, IT SOMETIMES COMES LOOSE (CAUSING A LEAK) , AND SOMETIMES EVEN STARTS TO PULL THE IV OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21694485 ↗
• InjuryOct 14, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT BD GRAVITY SET DISCONNECTED FROM THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE DO NOT HAVE THE PACKAGE OR THE LOT NUMBER, HOWEVER, WE DO HAVE THE PRODUCT THAT IS AVAILABLE TO RETURN IF NEEDED BUT WE WOULD NEED A BIOHAZARD KIT TO DO SO. PLEASE ADVISE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20440304 ↗
• MalfunctionAug 21, 2024Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20019079 ↗
• MalfunctionApr 7, 2024Defective Component; Defective Component

  NO ADDITIONAL INFO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19056983 ↗
• MalfunctionApr 4, 2024Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: HELLO, THE PROBLEM WAS THAT THE IV TUBING WAS DISCONNECTING FROM THE CHAMBER AT THAT JUNCTION. USUALLY IT HAPPENED WHILE WE WERE PRIMING THE TUBING AND THE DATES WERE THE WEEK OF (B)(6). THERE WERE FOUR TUBINGS THAT THIS OCCURRED TO AND IT IS THE SAME PROBLEM WE HAVE HAD IN THE PAST. TODAY IT HAPPENED AGAIN BUT THIS TIME, IT WAS ATTACHED TO THE PATIENT AND OCCURRED AS WE WERE BRINGING THE PATIENT FROM THE OR TO THE RECOVERY ROOM. IT DISCONNECTED AT THAT SAME JUNCTION AND THE FLUID WENT ALL OVER THE FLOOR AND IT SCARED THE PATIENT. WE HAD TO DISCONTINUE THE IV AT THAT TIME. ANOTHER PROBLEM HAPPENED TODAY. WHEN I TRIED TO CONNECT THE TUBING TO THE IV ANGIO, IT LEAKED AND COULD NOT BE CONNECTED PROPERLY. IT WAS SCREWED ALL THE WAY IN BUT IT KEPT LEAKING. BLOOD AND IV FLUID LEAKED ALL OVER THE OR CHAIR AND THE FLOOR. I HAD TO USE ANOTHER BAG AND TUBING AND CONNECTED IT TO THE ANGIO THAT SOMEHOW MANAGED TO STAY IN THE PERSON¿S VEIN AND WE CONTINUED ON WITH THE CASE. I COULD NOT KEEP THIS TUBING AS THERE WAS A LOT OF BLOOD IN IT AND IT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19048031 ↗