BD SmartSite 42502ERecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10885403235382), received between Mar 28, 2019 and Jun 30, 2023 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING BD ALARIS SMARTSITE GRAVITY SET FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS WHAT APPEARS TO BE MOLD FOUND IN ONE OF THE SPIKE¿S OF THE IV TUBING, SMART SITE GRAVITY SET. WE ARE PULLING ALL THE LOT #S THAT ARE THE SAME AS THE ONE THE MOLD WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17240240 ↗
• MalfunctionMar 20, 2023Backflow; Leak/Splash; Backflow; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SET HAD BLOOD BACKFLOW DURING THE INFUSION AND LEAK ONTO THE FLOOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE DID HAVE LEAKAGE FOR ALL SEPARATIONS, INCLUDING BACKFLOW OF BLOOD FROM PT ONTO FLOOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16572376 ↗
• MalfunctionMar 17, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SET SEPARATED FROM THE TUBING AND LEAKED BLOOD AND ANESTHESIA ONTO THE FLOOR DURING THE ANESTHESIA INDUCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I DO NOT HAVE EXACT DATES OF WHICH WE HAVE SEPARATION/CLAMP ISSUES WITH THE TUBING. WE DID HAVE LEAKAGE FOR ALL SEPARATIONS, INCLUDING BACKFLOW OF BLOOD FROM PT ONTO FLOOR. ANESTHESIA HAS ALSO REPORTED LEAKAGE OF FLUIDS AND MEDICATIONS DURING OPERATING ROOM CASES, BUT I CANNOT SPEAK TO WHICH PATIENTS/MEDICATIONS THIS OCCURRED WITH OR TO ANY ADVERSE AFFECTS TO THOSE PATIENTS... OCCURRED ON 2/3 DURING THE INDUCTION OF ANESTHESIA. PATIENT WAS PARTIALLY ASLEEP WHEN THE LINE STATED TO BACK UP. UPON LOOKING AT THE USUAL LOCATIONS FOR POSSIBLE BREAK IN LINE CONTINUITY, WE FOUND THIS AND HAD TO QUICKLY REPLACE THE TUBING... THESE OCCURRENCES ARE NOT ISOLATED AND OCCUR ALMOST EVERY GIVEN DAY SINCE WE HAVE CHANGED OUR PRODUCT TO THE CURRENT ONE. I AM NOT SURE OF LOT NUMBERS BUT HAS OCCURRED OVER THE YEAR IN 2022 AND NOW 2023. DESPITE NURSING AND ANESTHESIA TIGHTENING THE CONNECTIONS THEN STILL WILL LOOSEN TO THE POINT OF SEPARATION AND MEDICATION OR FLUIDS RUNNING O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16564756 ↗
• MalfunctionMar 17, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SET SEPARATED FROM THE TUBING AND LEAKED FLUID ONTO THE FLOOR DURING THE ENDOSCOPY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I DO NOT HAVE EXACT DATES OF WHICH WE HAVE SEPARATION/CLAMP ISSUES WITH THE TUBING. WE DID HAVE LEAKAGE FOR ALL SEPARATIONS, INCLUDING BACKFLOW OF BLOOD FROM PT ONTO FLOOR. ANESTHESIA HAS ALSO REPORTED LEAKAGE OF FLUIDS AND MEDICATIONS DURING OPERATING ROOM CASES, BUT I CANNOT SPEAK TO WHICH PATIENTS/MEDICATIONS THIS OCCURRED WITH OR TO ANY ADVERSE AFFECTS TO THOSE PATIENTS. FINALLY ANOTHER TOOK PLACE LATER IN THE FOLLOWING WEEK AROUND THURSDAY OR FRIDAY WHEN IT OCCURRED TO ME DURING AN ENDOSCOPY CASE DURING INDUCTION AGAIN. THESE OCCURRENCES ARE NOT ISOLATED AND OCCUR ALMOST EVERY GIVEN DAY SINCE WE HAVE CHANGED OUR PRODUCT TO THE CURRENT ONE. I AM NOT SURE OF LOT NUMBERS BUT HAS OCCURRED OVER THE YEAR IN 2022 AND NOW 2023. DESPITE NURSING AND ANESTHESIA TIGHTENING THE CONNECTIONS THEN STILL WILL LOOSEN TO THE POINT OF SEPARATION AND MEDICATION OR FLUIDS RUNNING ON BED OR FLOOR AND BLOOD BACKING UP IN THE TUBING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16564755 ↗
• MalfunctionMar 17, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SET SEPARATED FROM THE TUBING AND LEAKED FLUID ONTO THE FLOOR DURING THE EMERGENCY C-SECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I DO NOT HAVE EXACT DATES OF WHICH WE HAVE SEPARATION/CLAMP ISSUES WITH THE TUBING. WE DID HAVE LEAKAGE FOR ALL SEPARATIONS, INCLUDING BACKFLOW OF BLOOD FROM PT ONTO FLOOR. ANESTHESIA HAS ALSO REPORTED LEAKAGE OF FLUIDS AND MEDICATIONS DURING OPERATING ROOM CASES, BUT I CANNOT SPEAK TO WHICH PATIENTS/MEDICATIONS THIS OCCURRED WITH OR TO ANY ADVERSE AFFECTS TO THOSE PATIENTS. ANOTHER EVENT OCCURRED ON DURING (B)(6) AN EMERGENCY C-SECTION BY ANOTHER PROVIDER WHICH CAUSED THE SITUATION TO BE WRITTEN UP AGAINST MY PROVIDER. THESE OCCURRENCES ARE NOT ISOLATED AND OCCUR ALMOST EVERY GIVEN DAY SINCE WE HAVE CHANGED OUR PRODUCT TO THE CURRENT ONE. I AM NOT SURE OF LOT NUMBERS BUT HAS OCCURRED OVER THE YEAR IN 2022 AND NOW 2023. DESPITE NURSING AND ANESTHESIA TIGHTENING THE CONNECTIONS THEN STILL WILL LOOSEN TO THE POINT OF SEPARATION AND MEDICATION OR FLUIDS RUNNING ON BED OR FLOOR AND BLOOD BACKING UP IN THE TUBING. ON THE TWO MOST SERIOUS RECENT SEPARATIONS, THE PATIENT WAS IMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16564752 ↗
• MalfunctionMar 17, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED THAT 2 BD ALARIS SMARTSITE GRAVITY SET EXPERIENCED COMPONENT SEPARATION AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ANESTHESIA ALSO DID NOT KEEP THE TUBING THAT THEY HAD ISSUES WITH, THEY TOSSED THEM. THEY HAD 2 FAILURES JUST THIS PAST WEEK WHERE TUBING BECAME DISCONNECTED AND PATIENTS DID NOT RECEIVE THE MEDICATION THAT WAS BEING ADMINISTERED. WE USUALLY TOSS THE TUBING THAT IS MISSING ROLLER CLAMPS, WE NOTICE THE CLAMPS ARE MISSING AFTER SPIKING FLUIDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16562781 ↗
• MalfunctionMar 16, 2023Material Separation; Component Missing; Material Separation; Component Missing

  IT WAS REPORTED THAT 2 BD ALARIS SMARTSITE GRAVITY SET EXPERIENCED MISSING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ANESTHESIA ALSO DID NOT KEEP THE TUBING THAT THEY HAD ISSUES WITH, THEY TOSSED THEM. THEY HAD 2 FAILURES JUST THIS PAST WEEK WHERE TUBING BECAME DISCONNECTED AND PATIENTS DID NOT RECEIVE THE MEDICATION THAT WAS BEING ADMINISTERED. WE USUALLY TOSS THE TUBING THAT IS MISSING ROLLER CLAMPS, WE NOTICE THE CLAMPS ARE MISSING AFTER SPIKING FLUIDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16553806 ↗
• MalfunctionFeb 10, 2023Disconnection; Leak/Splash; Disconnection; Leak/Splash

  IT WAS REPORTED THAT 2 BD ALARIS¿ SMARTSITE¿ GRAVITY SET DISCONNECTS CAUSING IT TO LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OF THE PRIMARY SETS WE HANG WE HAVE ISSUES WITH LEAKING/DISCONNECTING IN PLACES THAT DO NOT EVEN THREAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16348667 ↗
• MalfunctionFeb 10, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SET WAS MISSING THE ROLLER CLAMPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ADDITIONALLY THEY HAD SEVERAL PRIMARY SETS TODAY WITH MISSING ROLLER CLAMPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16348666 ↗
• MalfunctionFeb 4, 2023Leak/Splash; Defective Component; Leak/Splash; Defective Component

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SET HAD A HOLE CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I ONLY KNOW OF TWO SETS THAT HAD HOLES IN THEM AND I HAVE ONE OF THOSE NOW THAT OCCURRED YESTERDAY. THERE WAS LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16301158 ↗
• MalfunctionFeb 4, 2023Leak/Splash; Defective Component; Leak/Splash; Defective Component

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SET HAD A HOLE CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I ONLY KNOW OF TWO SETS THAT HAD HOLES IN THEM AND I HAVE ONE OF THOSE NOW THAT OCCURRED YESTERDAY. THERE WAS LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16301156 ↗
• MalfunctionFeb 4, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT 2 BD ALARIS¿ SMARTSITE¿ GRAVITY SET CAME WITHOUT CLAMPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM AWARE OF AT LEAST FOUR WITHOUT CLAMPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16301072 ↗
• MalfunctionJan 26, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SET HAD DISCONNECTED IN A NON-THREADED PLACE AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS WAS DISCONNECTED IN A PLACE THAT DOESN'T EVEN THREAD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16251263 ↗
• MalfunctionJan 25, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT 2 BD ALARIS¿ SMARTSITE¿ GRAVITY SETS HAD HOLES IN THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THEY ALSO TOLD ME TODAY THAT THEY ARE HAVING SOME WITH HOLES IN THEM".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16244645 ↗
• MalfunctionJan 25, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SET HAD NO ROLLER CLAMP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE USE THE 42502E GARVITY SETS BD/ALARIS , AND I HAVE BEEN RECEIVING COMPLAINTS FROM DEPARTMENTS THAT THESE DO NOT HAVE THE ROLLER CLAMPS ATTACHED TO THEM OR IN THE PACKAGING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16244641 ↗
• MalfunctionDec 27, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 4 BD ALARIS¿ SMARTSITE¿ GRAVITY SETS LEAKED FLUID DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I¿VE HAD A FEW NURSES COME TO ME AND SAY THAT FLUID IS LEAKING FROM OUR ANESTHESIA TUBING ITEM #42502E. THEY ALL SEEM TO BE THE SAME LOT NUMBER 22069211."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16057399 ↗
• MalfunctionMar 28, 2019Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE ANESTHESIA TEAM REPORTED THAT WHEN THE PATIENT WAS MOVING FROM THE STRETCHER TO THE OR TABLE AND THE TECHNICIAN WENT TO PUT THE IV FLUIDS ON THE POLE THE TUBING DISCONNECTED WHERE THE 4 WAY STOPCOCK ATTACHES TO THE REST OF THE SET AND THE FLUID SPILLED OUT. THERE WAS NO HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8460647 ↗
• MalfunctionMar 28, 2019Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE ANESTHESIA TEAM REPORTED THAT THE TUBING IS DISCONNECTING WHERE THE 4 WAY STOPCOCK PORT ATTACHES TO THE REST OF THE SET WHILE CONNECTED TO A PATIENT AND FLUID IS SPILLING OUT. THERE WAS NO HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8460449 ↗
• MalfunctionMar 28, 2019Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE ANESTHESIA TEAM REPORTED THAT THE TUBING IS DISCONNECTING WHERE THE 4 WAY STOPCOCK ATTACHES TO THE REST OF THE SET WHILE CONNECTED TO A PATIENT. THE ANESTHESIA PROVIDER WAS PUSHING IV PROPOFOL AND NOTED THE PATIENT WAS NOT GOING TO SLEEP, SO HE LIFTED THE TUBING AND NOTICED IT WAS DISCONNECTED AND THE MEDICATION WAS SPILLING ON THE FLOOR. THE PATIENT SUSTAINED AN IV INFILTRATION WITH NO LASTING HARM.

  Patient problems: Inadequate Pain Relief; Infiltration into Tissue

  MAUDE report 8460445 ↗
• MalfunctionMar 28, 2019Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE ANESTHESIA TEAM REPORTED THAT THE TUBING IS DISCONNECTING WHERE THE 4 WAY STOPCOCK ATTACHES TO THE REST OF THE SET WHILE CONNECTED TO A PATIENT AND FLUID (SALINE, VERSED, FENTANYL) IS SPILLING OUT. THERE WAS NO HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8460353 ↗
• MalfunctionMar 28, 2019Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE ANESTHESIA TEAM REPORTED THAT THE TUBING IS DISCONNECTING WHERE THE 4 WAY STOPCOCK PORT ATTACHES TO THE REST OF THE SET WHILE CONNECTED TO A PATIENT AND FLUID IS SPILLING OUT. THERE WAS NO HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8460289 ↗