BD SmartSite 10010903Recalls & reported problems
BD Switzerland Sàrl · Gravity Blood Set, with Pressure Pump, 180 Micron Filter, Needle-Free Valve, Nonvented 264 cm (104 in) · Class 2
All models of BD SmartSite (29)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD SmartSite gravity blood set is a disposable IV administration set with a pressure pump, filter and needle-free valve. The 76 reports mostly describe leaking or splashing, material separating at connections, and blood or fluid not flowing — including chambers that only drip after being flicked or banged, sometimes blocking flow entirely. One report describes a death and one an injury. No recalls name this device.
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
- 73
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 07613203020879), received between Aug 23, 2018 and Aug 20, 2026 — classified as 1 death, 1 injury, 71 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (18 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
- Leak/Splash18
- Material Separation13
- Infusion or Flow Problem9
- Complete Blockage7
- Obstruction of Flow7
- Disconnection4
- Fluid/Blood Leak4
- Restricted Flow rate4
Patient problems
- No Clinical Signs, Symptoms or Conditions58
- No Consequences Or Impact To Patient8
- No Information4
- Death1
- Low Blood Pressure/ Hypotension1
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50355947 ↗MalfunctionAug 20, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50355508 ↗MalfunctionFeb 10, 2026Product Quality Problem; Material Twisted/Bent
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24309912 ↗MalfunctionSep 9, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT BD ALARIS GRAVITY SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THAT THE CHAMBER DOESN'T DRIP UNLESS YOUR FLICK IT OR BANG IT ON A TABLE. EVERY SINGLE SET HAS BEEN DOING THIS ACCORDING TO THE PROVIDERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23004692 ↗MalfunctionAug 26, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT BD ALARIS GRAVITY SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT THE CHAMBER DOESN'T DRIP UNLESS YOUR FLICK IT OR BANG IT ON A TABLE. EVERY SINGLE SET HAS BEEN DOING THIS ACCORDING TO THE PROVIDERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22895675 ↗MalfunctionAug 1, 2025Missing Information; Missing Information
IT WAS REPORTED THAT BD SMARTSITE GRAVITY PUMP SET WAS MISSING INFORMATION THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT LEAKING AND MISSING LOT AND EXPIRATION DATE INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22689054 ↗MalfunctionAug 1, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD SMARTSITE GRAVITY PUMP SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM S REPORTED BY CUSTOMER THAT LEAKING AND MISSING LOT AND EXPIRATION DATE INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22689052 ↗MalfunctionJul 14, 2025Improper Flow or Infusion; Improper Flow or Infusion
IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE LACK OF STRONG FLOW OF THEIR GRAVITY HAND PUMP BLOOD SET #10010903 AND THE PUMP SET WHEN RUN AS GRAVITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22494928 ↗MalfunctionJul 14, 2025Improper Flow or Infusion; Improper Flow or Infusion
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 THE LACK OF STRONG FLOW OF THEIR GRAVITY HAND PUMP BLOOD SET #10010903 AND THE PUMP SET WHEN RUN AS GRAVITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22494925 ↗MalfunctionJun 11, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY BLOOD SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT UPPER SEAL OF HAND PUMP ON BD SMARTSITE GRAVITY BLOOD SET (HAND PUMP BLOOD TUBING) FAILED WHILE SQUEEZING HAND PUMP, CAUSING BLOOD TO SPRAY CAREGIVER. THE AREA IN WHICH THE BLOOD LEAKED/SPRAYED OUT OF WAS COVERED IN A TEGADERM FOR EASIER IDENTIFICATION OF DEFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22189668 ↗MalfunctionJun 3, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT BD ALARIS SMARTSITE BLOOD GRAVITY SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT THE TUBING IS MORE PRONE TO KINKING AND OBSTRUCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22137720 ↗MalfunctionMay 29, 2025Material Discolored; Material Discolored
IT WAS REPORTED THAT BD AALRIS SMARTASITE GRAVITY BLOOD SET WAS DISCOLORED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED THAT PER THE DCHU, THE SAMPLE ARRIVED WITH A DISCOLORED COSMETIC DEFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22108450 ↗MalfunctionMay 12, 2025Leak/Splash; Leak/Splash
MalfunctionMay 5, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY BLOOD SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE TUBING ITSELF GETS OCCLUDED FROM THE ROLLER CLAMPS. THIS IS ENOUGH TO STOP / SEVERELY LIMIT FLOW THROUGH THE TUBING. IF IT OCCURS, WE CAN MANUALLY PINCH THE TUBING TO TRY TO OPEN IT BACK UP. THE IV SET ISN'T DRIPPING, BECAUSE THE PORTION OF KINKED TUBING IS BEHIND THE ROLLER CLAMP. IV TUBING (ON THE BLOOD SETS AND ON THE SYRINGE PUMPS) SEEMS SOFTER AND MORE PRONE TO KINKING THAN WHAT WE PREVIOUSLY USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21962303 ↗MalfunctionMay 5, 2025Defective Component; Material Twisted/Bent; Defective Component; Material Twisted/Bent
T WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY BLOOD SET KINKED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE TUBING ITSELF GETS OCCLUDED FROM THE ROLLER CLAMPS. THIS IS ENOUGH TO STOP / SEVERELY LIMIT FLOW THROUGH THE TUBING. IF IT OCCURS, WE CAN MANUALLY PINCH THE TUBING TO TRY TO OPEN IT BACK UP. THE IV SET ISN'T DRIPPING, BECAUSE THE PORTION OF KINKED TUBING IS BEHIND THE ROLLER CLAMP. IV TUBING (ON THE BLOOD SETS AND ON THE SYRINGE PUMPS) SEEMS SOFTER AND MORE PRONE TO KINKING THAN WHAT WE PREVIOUSLY USED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21962300 ↗MalfunctionMar 18, 2025Increased Pump Speed; Increased Pump Speed
IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY BLOOD SET WAS STICKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT ONE WAY BALL VALVE FAILING TO ENGAGE, LEADING TO SIGNIFICANT AIR ENTRAINMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21630127 ↗MalfunctionMar 18, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY BLOOD SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT LOST ~1L OF BLOOD VERY QUICKLY. WE PUT IN A CRASH MAC CATHETER AND TRIED TO TRANSFUSE AS FAST AS POSSIBLE, BUT IT WOULD NOT GO IN FASTER THAN A SLOW DRIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21629931 ↗MalfunctionMar 17, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY BLOOD SET WAS UNDER INFUSING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM CONCERN DESCRIPTION: GYNE INJURED THE AORTA AND LOST ~1L OF BLOOD VERY QUICKLY. WE PUT IN A CRASH MAC CATHETER AND TRIED TO TRANSFUSE AS FAST AS POSSIBLE, BUT IT WOULD NOT GO IN FASTER THAN A SLOW DRIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21620540 ↗MalfunctionMar 17, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY BLOOD SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING . IT WAS REPORTED BY CUSTOMER THAT THE PROBLEM IS NARROW CALIBRE TUBING = HIGH RESISTANCE TO FLOW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21620539 ↗MalfunctionMar 17, 2025Free or Unrestricted Flow; Free or Unrestricted Flow
IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY BLOOD SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT THE PRODUCT IS INCONSISTENT, OFTEN SLOW AND INADEQUATE FLOW RATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21619968 ↗MalfunctionMar 17, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY BLOOD SET FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE PRODUCT IS INCONSISTENT, OFTEN SLOW AND INADEQUATE FLOW RATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21619967 ↗MalfunctionOct 30, 2024Disconnection; Disconnection
NO ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20570749 ↗MalfunctionOct 29, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20556581 ↗MalfunctionSep 12, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20202146 ↗MalfunctionJun 25, 2024Material Separation; Material Separation
IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY BLOOD SET SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE BAG SPIKES ARE SEPARATING FROM THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19608275 ↗
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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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