Alaris, SmartSite 42103E-07Recalls & reported problems
BD Switzerland Sàrl · Gravity Set Check Valve, 3 Needle-Free Valves Vented/Nonvented · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10885403225840), received between Jul 2, 2019 and Feb 14, 2024 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Material Separation” (7 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.
Reports received per month
Most reported problems
Device problems
- Material Separation7
- Disconnection6
- Leak/Splash2
- Break1
- Defective Component1
- Fluid/Blood Leak1
- Loose or Intermittent Connection1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- No Known Impact Or Consequence To Patient4
- No Consequences Or Impact To Patient2
- No Information2
- Insufficient Information1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 14, 2024Leak/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: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. IV TUBING DISCONNECTING AT DRIP CHAMBER AS WELL AS AT THE CONNECTION HUB AT TIMES. IV'S ARE FAILING BECAUSE OF THE FAULTY CONNECTION. LOOSE CONNECTIONS POSE AN INFECTION RISK TO PATIENTS IF THE SYSTEM IS NOT A TIGHTLY SECURED SYSTEM. PRODUCT#: 42103E-07 IV TUBING¿S ARE DISCONNECTING AT THE DRIP CHAMBER AND MOST RECENTLY TWICE THE TUBING FELL OUT OF THE DRIP CHAMBER WHILE CONNECTED TO A PATIENT AND THE IV FLUIDS THEN SPILLED OUT OF THE BAG AND REQUIRED THE PATIENT TO HAVE THE IV TUBING CHANGED FROM THEIR IV.
Patient problems: Insufficient Information
MAUDE report 18704705 ↗MalfunctionJan 29, 2024Material Separation; Material Separation
IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: 2194-PC - BASE OF DRIP CHAMBER BROKE OFF FROM TUBING AFTER TUBING SPIKED WITH AN IV REVIEW PRODUCT THIS HAS HAPPENED 3 OR 4 TIMES THAT HAS BEEN REPORTED OTHERS HAVE BEEN THROWN AWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18597415 ↗MalfunctionDec 6, 2023Leak/Splash; Defective Component; Leak/Splash; Defective Component
NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIAL#: 42103E-07. BATCH NUMBER#: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT PIECES BREAKING OFF TUBING . VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. PIECES BREAKING OFF TUBING. CUSTOMER RESPONSE: WHAT IS THE DATE OF EVENT? I WAS GIVEN THE TUBING LAST WEEK AND WAS MADE AWARE OF THE ISSUE THEN. WHEN DID YOU IDENTIFIED THE ISSUE? (BEFORE OR DURING USE) DURING USE. IF YOU IDENTIFIED THIS ISSUE DURING USE, DID IT LEAD TO ANY LEAK? YES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18275287 ↗MalfunctionOct 17, 2023Material Separation; Material Separation
IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: BASE OF DRIP CHAMBER BROKE OFF FROM TUBING AFTER TUBING SPIKED WITH AN IV.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17954500 ↗MalfunctionAug 8, 2023Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SET PACKAGING WAS FOUND OPEN AND UNSEALED BEFORE USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I DO NOT FEEL CONFIDENT THIS PRODUCT WILL WORK FOR OUR SYSTEM. AFTER TESTING THE CASE OF 100 SETS ¿ 14 WERE NOT CLINICALLY ACCEPTABLE." 12 SETS ¿ PULLED APART WHEN RIGHT OUT OF THE PACKAGE. 1 SET- KINKED AND LIKELY NOT USABLE. 1 SET- PACKAGE WAS OPENED AND NOT SEALED (NOT SURE IF THAT WAS DONE BY XXXX PRIOR TO ME GETTING THE LOT). THIS WAS NOTED BEFORE USE: WAS THERE ANY PATIENT INVOLVEMENT? NO, SEE PREVIOUS ANSWER. ANY ADVERSE EVENTS OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO, SEE PREVIOUS ANSWER. WHAT WAS THE PATIENT OUTCOME? N/A. WAS THERE ANY DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THIS EVENT? N/A. WHAT PROCEDURE WAS BEING PERFORMED? N/A. WHAT MEDICATION WAS USED IN THE PROCEDURE? N/A WAS THERE ANY MEDICAL INTERVENTION DUE TO THIS EVENT? N/A. ARE YOU ABLE TO RECONFIRM IS ¿PULLED APART WHEN RIGHT OUT OF THE PACKAGE¿ MEANT BY SEPARATION OF COMPONENT BUT NO LEAKAGE ISSUE? YES. ARE YOU ABLE TO RECONFIR
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17480905 ↗MalfunctionAug 8, 2023Material Separation; Material Separation
IT WAS REPORTED THAT 12 BD ALARIS¿ SMARTSITE¿ GRAVITY SETS PULLED APART WHEN REMOVING THEM FROM THE PACKAGING. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I DO NOT FEEL CONFIDENT THIS PRODUCT WILL WORK FOR OUR SYSTEM. AFTER TESTING THE CASE OF 100 SETS ¿ 14 WERE NOT CLINICALLY ACCEPTABLE. 12 SETS ¿ PULLED APART WHEN RIGHT OUT OF THE PACKAGE. 1 SET- KINKED AND LIKELY NOT USABLE. 1 SET- PACKAGE WAS OPENED AND NOT SEALED (NOT SURE IF THAT WAS DONE BY XXXX PRIOR TO ME GETTING THE LOT)".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17480898 ↗MalfunctionAug 8, 2023Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SET TUBING WAS KINKED DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I DO NOT FEEL CONFIDENT THIS PRODUCT WILL WORK FOR OUR SYSTEM. AFTER TESTING THE CASE OF 100 SETS ¿ 14 WERE NOT CLINICALLY ACCEPTABLE. 12 SETS ¿ PULLED APART WHEN RIGHT OUT OF THE PACKAGE. 1 SET- KINKED AND LIKELY NOT USABLE. 1 SET- PACKAGE WAS OPENED AND NOT SEALED (NOT SURE IF THAT WAS DONE BY PRIOR TO ME GETTING THE LOT)".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17480897 ↗MalfunctionFeb 8, 2023Material Separation; Material Separation
IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SET TUBING SEPARATED FROM THE DRIP CHAMBER WHILE SPIKING THE IV BAG. THIS OCCURRED WITH 3 DIFFERENT SETS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD SMARTSITE GRAVITY IV SETS HAVE SEPARATED AT TOP WHERE DRIP CHAMBER MEETS TUBING. THE TUBING LITERALLY SEPARATES WHEN TRYING TO SPIKE AN IV BAG. IT DOES NOT SEEM AS THOUGH THE TWO PIECES ARE SEALED TOGETHER, BECAUSE THE SEPARATION IS CLEAN. THIS MUST BE AN INFECTION CONTROL ISSUE. BD IV TUBING DISCONNECTING/SEPARATING BELOW THE DRIP CHAMBER."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16318803 ↗MalfunctionOct 25, 2022Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SET TUBING CAME LOOSE FROM THE FLUID CHAMBER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE IV TUBING THAT WE ARE USING FOR OUR SURGICAL PATIENT IS BREAKING APART. THE TUBING CONNECTED TO THE FLUID CHAMBER IS BECOMING DISCONNECTED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15670672 ↗MalfunctionJun 20, 2022Break; Break
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET BROKE IN MIDDLE OF LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING BROKE IN MIDDLE OF LINE WHILE PREPARING IV FLUID.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14748384 ↗MalfunctionMay 21, 2022Material Separation; Material Separation
¿IT WAS REPORTED THAT THE BD PRIMARY GRAVITY IV ADMINISTRATION SETS - IV GRAVITY SET EXPERIENCED SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING CAME APART AT DISTAL PORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14465822 ↗MalfunctionMay 20, 2022Material Separation; Material Separation
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET CAME APART AT THE DISTAL PORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LAIN IV TUBING USED FOR DSE, CAME APART AT DISTAL PORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14462317 ↗MalfunctionFeb 5, 2020Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE TUBING HAD A SMALL SLIT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION AND PATIENT DEMOGRAPHICS WERE NOT PROVIDED.
Patient problems: No Information
MAUDE report 9673038 ↗MalfunctionJul 24, 2019Disconnection; Disconnection
IT WAS REPORTED THAT THE SET DISCONNECTED, POPPED OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8822881 ↗MalfunctionJul 24, 2019Disconnection; Material Separation; Disconnection; Material Separation
IT WAS REPORTED THAT THE SET DISCONNECTED, POPPED OFF.
Patient problems: No Information
MAUDE report 8822825 ↗MalfunctionJul 24, 2019Disconnection; Disconnection
IT WAS REPORTED THAT THE SET DISCONNECTED, POPPED OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8822426 ↗MalfunctionJul 24, 2019Disconnection; Disconnection
IT WAS REPORTED THAT THE SET DISCONNECTED, POPPED OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8822422 ↗MalfunctionJul 24, 2019Disconnection; Disconnection
IT WAS REPORTED THAT THE SET DISCONNECTED, POPPED OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8822327 ↗MalfunctionJul 2, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER NOTIFIED BD WITH A REPORTED ISSUE OF A SET LEAKING AT THE FIXED COLLAR ABOVE SPIN COLLAR. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8753172 ↗MalfunctionJul 2, 2019Disconnection; Disconnection
THE CUSTOMER NOTIFIED BD WITH A REPORTED ISSUE OF BD SYRINGES THAT ARE NOT STAYING CONNECTED TO THE SMARTSITE PORT BELOW THE DRIP CHAMBER. NO PATIENT HARM WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8753166 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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