BD SmartSite 42519ERecalls & reported problems
BD Switzerland Sàrl · Gravity Set, Check Valve 2 Needle-Free Valves, 3 Port Manifold, Vented/ Nonvented, 300 cm (118 in) · Class 2
All models of BD SmartSite (29)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613203010870), received between Sep 12, 2022 and Jan 10, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash3
- Loose or Intermittent Connection2
- Component Missing1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 10, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET WAS DAMAGED AND LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: "WE HAD AN ISSUE TODAY WITH THE SUB ANESTHESIA TUBING FROM BD. THIS WAS BEING USED ON A CT PATIENT AND WAS CAUGHT RIGHT AWAY WHEN FLUID STARTED SPURTING OUT THE BACK OF THE MANIFOLD AND FROM THE SPLIT. THE TUBING SPLIT OPEN AS YOU SEE IN THE FIRST PIC AND WAS ALSO LEAKING AT THE BACK OF THE MANIFOLD. THIS HAPPENED WHEN THEY WERE GIVING SEDATION AND CONTRAST TO THE PATIENT. THE PATIENT WAS WAKING AND TRYING TO PULL THINGS OUT. THE PROVIDER SAID IF THIS WAS A CASE WHERE THE ARMS WERE TUCKED THEY WOULD NOT HAVE KNOWN RIGHT AWAY THAT THERE WAS AN ISSUE. I HAVE ASKED MY TECHS TO PULL WHAT WE HAVE LEFT OF THIS TUBING ON THE SHELVES RIGHT NOW. I WASN¿T SURE HOW MANY ARE IN THE STORE ROOM. I AM THINKING WE MAY HAVE TO FIND ANOTHER SUB, NOT SURE WE CAN TRUST THIS TUBING." "I WOULD BE AVAILABLE TO SPEAK THIS MORNING AND CAN BE REACHED AT (B)(6). IF YOU ARE LOOKING TO TALK ABOUT WHAT WE NEED WITH THE 32 CASES, THEN I WOULD BE THE PERSON TO SPEAK WITH. IF YOU ARE LOOKING TO TALK ABOUT THE PRODUCT FAILURE, THEN IT WOULD BE BEST TO TALK T
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18489909 ↗MalfunctionFeb 8, 2023Component Missing; Component Missing
IT WAS REPORTED THAT 2 BD ALARIS¿ SMARTSITE¿ GRAVITY SETS WERE MISSING THEIR ROLLER CLAMPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " I HAVE A FEW MORE OF THE 42519E IV SETS THAT ARE DEFECTIVE. TWO ARE MISSING THE ROLLER CLAMPS".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16319132 ↗MalfunctionFeb 7, 2023Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SET HAD A LOOSE CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " I HAVE A FEW MORE OF THE 42519E IV SETS THAT ARE DEFECTIVE... 1 THE CONNECTIONS ARE NOT TIGHT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16317632 ↗MalfunctionDec 19, 2022Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection
IT WAS REPORTED THAT 2 OF THE BD GRAVITY ADMINISTRATION SETS WERE LOOSE AND LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HI, I HAVE 2 DEFECTIVE IV SETS REFERENCE# (B)(4). THEY ARE BOTH THE SAME LOT NUMBER (10)22059085. THEY HAD LOOSE AND LEAKING CONNECTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16005239 ↗MalfunctionSep 12, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SET LEAKED AT THE CONNECTION BETWEEN THE TUBING AND MANIFOLD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS BROUGHT TO MY ATTENTION THAT A PROVIDER FOUND BD IV GRAVITY TUBING SET (42519E) LEAKING AT THE POINT OF CONTACT BETWEEN THE TUBING AND THE MANIFOLD... ADDITIONALLY, WITHIN THE SAME LOT NUMBER WE FOUND MULTIPLE IV TUBING SETS TO HAVE BEEN MANUFACTURED POORLY AT THE SAME CONTACT POINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15405553 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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