Medex MX20108Recalls & reported problems
Icu Medical, Inc. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10351688509772), received between Mar 25, 2024 and Mar 25, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Disconnection” (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
- Disconnection1
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.
InjuryMar 25, 2024Disconnection; Disconnection
IT WAS REPORTED THAT THEY HAVE HAD MULTIPLE INCIDENTS OF THE NEEDLELESS CONNECTORS FALLING OUT WHEN THEY¿RE SUPPOSED TO BE BONDED ON. THE 8-PORT MANIFOLD WAS INFUSING MYCOPHENYLATE (HAZARDOUS DRUG) WHEN ANOTHER MANIFOLD PORT WITH USED TUBING FOR GANCICLOVIR (ALSO HAZARDOUS) DISCONNECTED BELOW NEEDLELESS CONNECTOR. THEY HAVE BEEN SEEING AND REPORTING THE SAME DEFECT. THIS CAUSED A HAZARDOUS MEDICATION SPILL OF MYCOPHENYLATE ~100 ML. INHERENT HAZARDOUS DRUG EXPOSURE RISK TO STAFF, PATIENT, OTHERS, AND INFECTION RISK FROM OPEN TUBING. CAUSED INTERRUPTION OF VITAL IV THERAPIES WASTE/COST OF REPLACEMENT THERAPIES AND TUBING. THERE WAS KNOWN PATIENT INVOLVEMENT AND PATIENT HARM. PRODUCT WILL NOT BE RETURNED DUE TO HAZARDOUS DRUG SPILL. ADVERSE PATIENT EFFECTS AND TREATMENT WERE NOT PROVIDED.
Patient problems: Chemical Exposure
MAUDE report 18975045 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.