RATE FLOW® 375256Recalls & reported problems
B. Braun Medical Inc. · RATEFLOW EXT SET W/ 1 CARESITE · Class 2
- 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 04046955256952), received between Jun 10, 2024 and Jun 10, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Excess Flow or Over-Infusion1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 10, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
AS REPORTED BY THE USER FACILITY: REPORTED ISSUE: WE WERE USING THE DIAL A FLOW WITH VANCOMYCIN RUNNING AND NO MATTER WHAT THE DIAL WAS SET TO, IT FLOWED FREELY CAUSING A REACTION TO THE PATIENT UNTIL THE ISSUE WAS CAUGHT.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 19505159 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.