BD SmartSite 42511ERecalls & reported problems
BD Switzerland Sàrl · Gravity Set, Check Valve 4-Way Stopcock, 2 One-Way Valves, Needle-Free Valve, Vented/ Nonvented, Extension Set, with Needle-Free Valve, 292 cm (115 in) · Class 2
Quick summary
This is a BD SmartSite gravity IV administration set with a four-way stopcock and needle-free valves. The 33 reports mostly describe fluid not flowing through the tubing, ports that will not run or flush, blocked lines, and parts separating or coming apart, with no deaths or injuries reported. There are no recalls naming this device. Reports in the last 12 months dropped from 15 to none.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10885403235412), received between Dec 21, 2021 and Aug 25, 2025 — classified as 33 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (8 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.
Reports received per month
Most reported problems
Device problems
- Obstruction of Flow8
- Complete Blockage3
- Component Missing3
- Defective Component3
- Material Separation3
- Component Misassembled2
- Device Contamination with Chemical or Other Material2
- Disconnection2
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- Insufficient Information5
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD SMARTSITE GRAVITY SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT WHEN NURSES SPIKE A BAG OF FLUIDS, THE FLUIDS WILL NOT RUN THROUGH THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22886671 ↗MalfunctionAug 9, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22766717 ↗MalfunctionAug 9, 2025Component Misassembled; Component Misassembled
IT WAS REPORTED THAT THE UNSPECIFIED BD INFUSION SET WAS DAMAGED / MISASSEMBLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ROLLER CLAMP UPSIDE DOWN. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: WILL YOU CONFIRM IF THE MATERIAL OR BATCH NUMBER IS KNOWN FOR THESE EVENTS? I CANNOT CONFIRM A LOT #. THE TUBING WAS ALREADY IN USE AND PACKAGING HAD ALREADY BEEN DISPOSED OF EARLY IN THE DAY. DESCRIBE IF ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME OCCURRED AS A RESULT OF EACH EVENT. ROLLER CLAMP UPSIDE DOWN-NO PATIENT HARM OR NEGATIVE OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22766713 ↗MalfunctionAug 8, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PROPOFOL REMAINS IN THE CAP UNTIL IT IS FLUSHED MOST OF THE TIME, REQUIRING MULTIPLE FLUSHES TO CLEAR THE LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22755708 ↗MalfunctionAug 8, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WILL NOT FLOW TO GRAVITY FROM THOSE 2 PORTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22755706 ↗MalfunctionAug 8, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CAN'T DRAW BACK FROM 2 OF THE PORTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22755331 ↗MalfunctionAug 8, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV MICRO GTT CANNOT FREE FLOW THROUGH TWO OF THE PORTS. WILL ONLY FREE FLOW THROUGH THE STOPCOCK PORT OR THE Y SITE CLOSE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22751029 ↗MalfunctionAug 8, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: POTENTIAL FLOW ISSUE WHEN ADMINISTERING SECONDARY MEDICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22750753 ↗MalfunctionAug 8, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAME 2 PORTS DO NOT ALLOW FOR GRAVITY GTT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22750130 ↗MalfunctionAug 8, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CAN'T DRAW BACK FROM THE 2 PORTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22750129 ↗MalfunctionAug 8, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET HAD DISCONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1ST CASE THE CLAVE DISCONNECTED AND FELL OFF DURING TRANSPORT TO THE OR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22749973 ↗MalfunctionAug 8, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CAN'T DRAW BACK FROM 2 PORTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22749970 ↗MalfunctionAug 8, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAD TO REMOVE THE POSITIVE PRESSURE CAP @ PIGTAIL BECAUSE IT WOULD NOT FLOW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22746588 ↗MalfunctionAug 8, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS ONLY ONE PORT THAT YOU HAVE THE ABILITY TO DRAW BACK FROM (STOPCOCK PORT) THE OTHER 2 PORTS DO NOT ALLOW YOU TO DRAW BACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22746582 ↗MalfunctionMay 5, 2025Component Missing; Component Missing
IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET WAS MISSING A COMPONENT. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT FEW GRAVITY SETS WERE MISSING TUBING AND CLAMPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21963408 ↗MalfunctionJun 21, 2024Disconnection; Disconnection
MATERIAL # LOT # IT WAS REPORTED BY CUSTOMER THAT TUBING BECOMING DISCONNECTED AT THE CONNECTION BETWEEN THE 3-WAY STOPCOCK AND EXTENSION TUBING. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. OUR STAFF HAVE HAD SOME CONCERNS WITH THE TUBING BECOMING DISCONNECTED AT THE CONNECTION BETWEEN THE 3-WAY STOPCOCK AND EXTENSION TUBING. THE TUBING APPEARS TO ONLY BE PARTIALLY SCREWED TOGETHER WHEN REMOVING FROM PACKAGING.
Patient problems: Insufficient Information
MAUDE report 19585166 ↗MalfunctionJun 21, 2024Material Separation; Material Separation
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 19584454 ↗MalfunctionDec 3, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: A PRE-OP NURSE NOTICED BROWN SPOTS ON MULTIPLE SPIKES OF THE BD SMARTSITE GRAVITY SET TUBING THIS MORNING. THE REFERENCE NUMBER IS (B)(4) . THE LOT NUMBER ON THE FRONT OF THE PACKAGING IS +H37042511E1A AND THE LOT ON THE BACK IS (10)23069114 WITH AN EXPIRATION DATE OF 2026-06-08.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18253698 ↗MalfunctionSep 12, 2023Material Separation; Material Separation
NO FURTHER INFORMATION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17731358 ↗MalfunctionAug 4, 2023Defective Component; Defective Component
IT WAS REPORTED WHILE USING BD ALARIS SMARTSITE W/MANIFOLD GRAVITY & EXT SET THE TUBING WAS CLOGGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THE TUBING DOES NOT PRIME DUE TO VALVE BEING PLACED ON BACKWARDS. THERE WAS NO PATIENT HARM REGARDING THE TUBING MENTIONED IN THE REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17466767 ↗MalfunctionAug 4, 2023Defective Component; Defective Component
IT WAS REPORTED WHILE USING BD ALARIS SMARTSITE W/MANIFOLD GRAVITY & EXT SET THERE WAS A BLOCKAGE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THE TUBING DOES NOT PRIME DUE TO VALVE BEING PLACED ON BACKWARDS. WAS THERE ANY PATIENT INVOLVEMENT? NA IF YES, WHAT IS THE PATIENT OUTCOME? NA IS THERE ANY ADVERSE EVENT/SERIOUS INJURY? NA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17466763 ↗MalfunctionAug 3, 2023Component Misassembled; Component Misassembled
IT WAS REPORTED WHILE USING BD ALARIS SMARTSITE W/MANIFOLD GRAVITY & EXT SET THE CHECK VALVE WAS PLACED BACKWARDS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEFECT - THE TUBING DOES NOT PRIME DUE TO VALVE BEING PLACED ON BACKWARDS. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? SPIKING A BAG OF IV FLUIDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17455483 ↗MalfunctionJul 21, 2023Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SET HAD A STOPCOCK HANDLE THAT WAS ASSEMBLED 180° IN OPPOSITE DIRECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT STOPCOCK HANDLE WAS ASSEMBLED 180° IN OPPOSITE DIRECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17374704 ↗MalfunctionJun 21, 2023Material Separation; Material Separation
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNFORTUNATELY THE DEVICE THAT FAILED WAS LOST IN CUSTOMS AND IS IRRETRIEVABLE AND THEREFORE NO PART IS AVAILABLE FOR INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17173183 ↗MalfunctionJun 16, 2023Defective Component; Defective Component
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET TUBING WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS TUBING FREQUENTLY COMES LOOSELY ASSEMBLED AND I'VE SEEN >10 UNINTENTIONAL DISCUSSIONS AT SECTIONS IF TUBING MEANT TO BE SCREWED TOGETHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17148735 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.