MedSystem III, SmartSite 28034ERecalls & reported problems
BD Switzerland Sàrl · Infusion Set, 292 cm (115 in) · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403274855), received between Jul 16, 2021 and Jul 16, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Free or Unrestricted Flow” (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.
Most reported problems
Device problems
- Free or Unrestricted Flow1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2021Leak/Splash; Free or Unrestricted Flow; Leak/Splash; Free or Unrestricted Flow
IT WAS REPORTED THAT MSIII 20D DEHP 2SS SETS WEREN'T FITTING IN THE PUMP AND THERE WAS AIR IN THE LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SOME SETS DO NOT FIT IN THE PUMP. IT WAS REPORTED THAT THERE HAVE BEEN MANY AIR IN LINE ALARMS FOR THESE SETS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12185990 ↗
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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 13, 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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