Codan BC 564Recalls & reported problems
Codan US Corporation · MiniBore Extension Set with Male Luer Lock · Class 2
Data updated Oct 13, 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 10813153020002), received between Mar 6, 2019 and Mar 6, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Connection Problem” (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.
Most reported problems
Device problems
- Connection Problem1
- Leak/Splash1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 6, 2019Leak/Splash; Connection Problem
IT HAS BEEN REPORTED BY OUR ANESTHESIOLOGISTS THAT THE CODAN MINIBORE EXTENTION SET WITH MALE LUERLOCK ARE DIFFICULT TO CONNECT TO THE FEMALE LUERLOCK ON THE PERIFIX CONTINIOUS EPIDURAL. THIS IS CAUSING MEDICATION TO LEAK FROM THIS CONNECTION LEADING TO UNNECESSARY LABOR PAIN. THIS PATIENT'S PAIN WAS ABLE TO BE CONTROLLED AFTER THIS CONNECTION WAS REINFORCED BY ANESTHESIA. THIS POOR CONNECTION MUST BE REINFORCED FREQUENTLY TO ASSURE THAT PATIENT'S EPIDURALS DO NOT LEAK.
Patient problems: Pain
MAUDE report 8394073 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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