Medex MX2311LRecalls & reported problems
Icu Medical, Inc. · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10351688508331), received between Aug 15, 2023 and Nov 20, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak2
- Disconnection1
- Leak/Splash1
- Material Separation1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2023Disconnection; Fluid/Blood Leak; Leak/Splash; Material Separation; Disconnection; Fluid/Blood Leak; Leak/Splash; Material Separation
ADDITIONAL INFORMATION WAS RECEIVED: IT WAS STATED THAT THERE WAS NO MEDICAL INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18173577 ↗InjuryAug 15, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AT APPROXIMATELY 0810, THE BEDSIDE NURSE WAS READYING THE BABY TO BE MOVED FROM HIS ISOLETTE TO AN OPEN CRIB. IN PREPARATION, HIS BLANKET WAS CHANGED TO ALLOW FOR SWADDLING AND EASY LIFTING FROM THE BED/HOLDING. DURING THE CHANGE, WHILE THE NURSE WAS BEING CAREFUL NOT TO ALLOW TENSION ON THE INFANTS UVC, THE THREE-WAY STOPCOCK AND IV TUBING HAD BECOME COMPLETELY DISCONNECTED FROM THE UVC. THE IV TUBING WAS INFUSING THE BABY'S TOTAL PARENTERAL NUTRITION (TPN) AND INTRALIPIDS. THE HEALTHCARE PROFESSIONAL IMMEDIATELY MANUALLY CLAMPED THE DISTAL PORTION OF THE UVC AND HELD IT UPRIGHT WHILE SIMULTANEOUSLY PAUSING THE IV INFUSIONS. ON FURTHER ASSESSMENT, NO EVIDENCE OF ANY LEAKAGE OF FLUID WAS FOUND. TWO ADDITIONAL NURSES WERE AT THE BEDSIDE WITH THE BEDSIDE NURSE (TO ASSIST WITH THE BED CHANGE) AT THE TIME THIS OCCURRED, SO ONE ASSISTED WITH CLAMPING THE LINE WITH A 2X2 GAUZE SQUARE AND PLASTIC HEMOSTAT WHILE THE OTHER WENT TO FIND HELP. UPON SUMMONING TWO OTHER NURSES TO THE BEDSIDE THE TBES WERE INVESTIGATED FOR FURTHER POTENTIAL LEAKING POINTS. ON FURTHER ASSESSMENT (WITH BEDSIDE NURSES ALL WORKING TOGETHER), NO EVIDENCE OF ANY LEAKAGE OF FLUID WAS FOUND - NEITHE
Patient problems: Insufficient Information
MAUDE report 17552337 ↗
Other Stopcock, i.V. Set devices
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- Outlook® 490361B. Braun Medical Inc. · Stopcock, i.V. Set3 recalls0 reports
- Blood Administration Set 490530B. Braun Medical Inc. · Stopcock, i.V. Set2 recalls11 reports
- Medex MX9341LIcu Medical, Inc. · Stopcock, i.V. Set63 reports
- ICU Medical AC135Icu Medical, Inc. · Stopcock, i.V. Set1 recall10 reports
- IV Administration Set 490067B. Braun Medical Inc. · Stopcock, i.V. Set1 recall9 reports
- ICU Medical MC330174Icu Medical, Inc. · Stopcock, i.V. Set1 recall4 reports
- ICU Medical Z2587Icu Medical, Inc. · Stopcock, i.V. Set1 recall3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.