Alaris 11582774Recalls & reported problems
BD Switzerland Sàrl · Secondary Set, 92 cm (36 in) · Class 2
All models of Alaris (85)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885403234750), received between Feb 8, 2022 and Aug 29, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Leak/Splash1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 29, 2022Material Separation; Material Separation
IT WAS REPORTED WHILE USING BD SEC 20DP NO PORTS W/HANGER DEHP FREE THE COMPONENTS WERE SEPARATED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE "TUBING WAS NOT CONNECTED TO CHAMBER". VERBATIM: EVENT DESCRIPTION: BEDSIDE RN OPENED SECONDARY IV TUBING SET AND NOTICED TUBING WAS NOT CONNECTED TO CHAMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15316231 ↗MalfunctionJul 15, 2022Break; Break
IT WAS REPORTED THAT THE BD SECONDARY IV ADMINISTRATION SETS EXPERIENCED DAMAGE PRODUCT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I DISCONNECTED ONE OF THE SECONDARY SETS FROM THE PRIMARY AND WHEN I WENT TO PUT A GREEN CAP ON THE END OF THE SECONDARY, THE CONNECTION PORT OF THE SECONDARY BROKE COMPLETELY AWAY FROM THE TUBING. THERE WAS NO HARM TO THE PATIENT BECAUSE THIS OCCURRED WHILE DETACHING A COMPLETED SECONDARY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15033016 ↗MalfunctionFeb 8, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD ALARIS¿ SECONDARY SET LEAKED FROM THE BOTTOM OF THE DRIP CHAMBER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKING AT BOTTOM OF DRIP CHAMBER OF TUBING"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13482868 ↗
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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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