Jelco 402115Recalls & reported problems
Icu Medical, Inc. · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00351688070862), received between Dec 30, 2024 and Jun 23, 2025 — classified as 3 malfunctions.
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
- Fail-Safe Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Needle Stick/Puncture1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 23, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED WHILE THE HEALTH CARE PROFESSIONAL ATTEMPTED TO RETRACT THE NEEDLE SAFETY MECHANISM ONTO THE MATTRESS FOLLOWING AN INTRAMUSCULAR INJECTION ADMINISTERED TO A PATIENT, ONE HAND SLIPPED, AND THE NEEDLE PRICKED THE LEFT INDEX FINGER IN TWO PLACES THAT RESULTED IN BLOOD EXPOSURE.
Patient problems: Needle Stick/Puncture
MAUDE report 22308007 ↗MalfunctionJan 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
PER MEDWATCH NUMBER MW5163216, IT WAS REPORTED THE NEEDLE WAS NOT OVERTIGHTENED. AFTER BEING PRIMED, THE FLUID LEAKED FROM THE NEEDLE. THIS HAPPENED BEFORE ADMINISTRATION TO THE PATIENT. THERE WERE NO ADVERSE EVENTS REPORTED DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21180232 ↗MalfunctionDec 30, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING THE SCHEDULED VISIT TO ADMINISTER A HYDROXOCOBALAMIN INJECTION, MEDICATION LEAKED FROM BETWEEN THE NEEDLE AND THE SYRINGE. DESPITE TIGHTENING THE NEEDLE TO THE SYRINGE, THE LEAKAGE CONTINUED, PREVENTING THE FULL DOSE FROM BEING ADMINISTERED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21037097 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.