Alaris 20022Recalls & reported problems
BD Switzerland Sàrl · Extension Set, Microbore Tubing 152 cm (60 in) · Class 2
All models of Alaris (85)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885403233265), received between Jun 28, 2019 and Mar 29, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2 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.
Most reported problems
Device problems
- Leak/Splash2
- Crack1
- Fluid/Blood Leak1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 29, 2023Crack; Leak/Splash; Crack; Leak/Splash
IT WAS REPORTED THAT THE BD MICROBORE TUBING EXTENSION SETS WAS CRACKED CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN NOTICED MOISTURE ON MEDLINE MEDFUSION PUMP. UPON FURTHER INVESTIGATION RN FOUND THAT THE EXTENSION TUBING WAS CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16639766 ↗MalfunctionNov 30, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS EXTENSION SET LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE MEDICATION LEAKED FROM CONNECTOR BETWEEN MICROBORE TUBING AND FILTER EXTENSION TUBING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12898361 ↗MalfunctionAug 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
PRODUCT WAS RECEIVED AS AN UNEXPECTED RETURN WITH AN UNSPECIFIED FAILURE.
Patient problems: No Information
MAUDE report 10376206 ↗MalfunctionJun 28, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT MICROBORE TUBING WAS NOTED TO BE LEAKING IN THE PEDIATRIC AREA. ALTHOUGH REQUESTED, THERE WERE NO FURTHER DETAILS OR INFORMATION PROVIDED AND NO REPORT OF HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8746370 ↗
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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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