Jelco 505311Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Jelco (101)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 15019315118616), received between Sep 15, 2021 and Sep 15, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2021Break; Break
INFORMATION WAS RECEIVED INDICATING A SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETERS (PIVC)/JELCO CONVENTIONAL OPTIVA IV CATHETER WAS INSERTED INTO THE PATIENT'S LEFT WRIST, AND IT WAS NOTED THAT THE TAPED WERE WET AND THE RN WAS UNABLE TO FLUSH THE IV WELL. WHEN THE TAPES WERE REMOVED IT WAS NOTED THE IV CATHLON WAS BROKEN OFF. THE CATHLON PEACE WAS STILL IN PATIENT SKIN. THE RN REMOVED THE CATHLON FROM THE PATIENT. MINOR INJURY WAS NOTED TO THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 12477542 ↗
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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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