BD SmartSite CS42522E-07Recalls & reported problems
BD Switzerland Sàrl · Gravity IV Set, 376 cm (148 in) with 3-port Closed Stopcock Manifold Back Check Valve 2 Needle-Free Y-sites · Class 2
All models of BD SmartSite (29)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403473753), received between Jan 2, 2024 and Apr 21, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Backflow” (1 report).
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
- Backflow1
- Infusion or Flow Problem1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 21, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT BD GRAVITY SET WAS KINKED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT THE KINKS IN TUBING THAT DO NOT RESOLVE AFTER RELEASING AND REPOSITIONING RESULTING IN RESTRICTED FLOW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21878658 ↗MalfunctionJan 2, 2024Backflow; Backflow
IT WAS REPORTED THAT BD GRAVITY SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED THAT LACTATED RINGER'S (LR) SOLUTION IS BACKING UP INTO THE SYRINGE FILLED WITH PROPOFOL MAKING IT CHALLENGING TO KNOW HOW MUCH PROPOFOL THEY ARE GIVING AT A TIME. THE FILLED PROPOFOL SYRINGE IS OFTEN LEFT ATTACHED TO THE TUBING WHERE THE DOSE IS CONSTANTLY BEING TITRATED FOR MAC CASES. THERE WAS NO INFORMATION ON PATIENT INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 18423453 ↗
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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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