Caresite Micro™ 354265Recalls & reported problems
B. Braun Medical Inc. · CARESITE Micro 8" Smallbore Extension Set · Class 2
All models of Caresite Micro (5)
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 04046955772865), received between May 20, 2026 and May 20, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash1
Patient problems
- Chemical Exposure1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2026Leak/Splash
THIS COMPLAINT DOCUMENTS THE CLAIMANT'S ALLEGATION THAT IN SOME INSTANCES, THE SECURITY CAP FALLS OFF AFTER THE TUBING HAS BEEN CONNECTED TO THE PATIENT'S IV SET UP, EVEN IN THE ABSENCE OF ANY JARRING OR EXTERNAL DISRUPTION. CUSTOMER ALLEGES THAT THIS CREATES A SIGNIFICANTLY INCREASED RISK OF STERILE END OF THE TUBING TOUCHING A CONTAMINATED SURFACE WHEN SETTING UP OR RECONNECTING A PATIENT IV. IN ONE SUCH INCIDENT THE B. BRAUN EXTENSION TUBING CAP ON AN IV CATHETER DISCONNECTED DURING CHEMOTHERAPY INFUSION RESULTING IN A BACKFLOW OF BLOOD AND CHEMOTHERAPY INFUSION ONTO THE PATIENT.
Patient problems: Chemical Exposure
MAUDE report 25234584 ↗
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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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