Jelco 305306Recalls & 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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10351688071156), received between Jul 8, 2022 and Aug 9, 2024 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture4
- Deformation Due to Compressive Stress1
- Difficult to Insert1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Abrasion1
- Bruise/Contusion1
- Insufficient Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 9, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AFTER INTRAVENOUS (IV) WAS PLACED ON PATIENT. AFTER SUCCESSFUL PLACEMENT, EXTENSION TUBING WAS CONNECTED AND WHEN FLUSHING, BLOOD AND SALINE WAS LEAKING FROM SIDE OF THE HUB. BLOOD RETURN WAS CHECKED, AND AIR CAME BACK INTO LINE WITH BLOOD. CRACK WAS ALSO NOTICED IN THE SIDE OF THE HUB. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19956186 ↗MalfunctionAug 25, 2022Difficult to Insert; Deformation Due to Compressive Stress; Difficult to Insert; Deformation Due to Compressive Stress
IT WAS REPORTED THAT IT IS NOT EASY TO PENETRATE THE SKIN AND PLASTIC PART KINKED OUTSIDE THE SKIN AND ALWAYS RUPTURE THE VEINS. NO PATIENT INJURY WAS REPORTED.
Patient problems: Abrasion
MAUDE report 15292382 ↗MalfunctionJul 8, 2022Fracture; Fracture
IT WAS REPORTED THAT UPON ATTEMPTING TO START A IV, THE METAL NEEDLE PERFORATED THE PLASTIC TUBING AT THE END OF THE HUB. THIS REQUIRED THE INFANT TO REQUIRE MULTIPLE IV ATTEMPTS. THIS EQUIPMENT FAILURE RESULTED IN TWO UNSUCCESSFUL IV ATTEMPTS, CAUSING SKIN PUNCTURE TO THE BABY UNNECESSARILY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14960972 ↗MalfunctionJul 8, 2022Fracture; Fracture
IT WAS REPORTED THAT WHILE USING THE 24G 3/4" PROTECT IV WITH OUT WINGS, AND WHITE CATHETER (JELCO), THE NEEDLE SHEATHED THROUGH THE IV CATHETER ON INSERTION. HAPPEN TO NOTICE THE NEEDLE SEPARATED FROM THE CATHETER AT THE INSERTION SITE WHILE IN THE BABY. THE CHILD, WITH LIMITED IV ACCESS, NEEDED A NEW IV SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14956687 ↗MalfunctionJul 8, 2022Fracture; Fracture
IT WAS REPORTED THAT THE NEEDLE SHEATHED THROUGH THE IV CATHETER ON INSERTION. HAPPEN TO NOTICE THE NEEDLE SEPARATED FROM THE CATHETER AT THE INSERTION SITE WHILE IN THE BABY. THE CHILD, WITH LIMITED IV ACCESS, NEEDED A NEW IV SITE.
Patient problems: Bruise/Contusion; Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14956632 ↗MalfunctionJul 8, 2022Fracture; Fracture
IT WAS REPORTED THAT UPON ATTEMPTING TO START A IV, WHEN THREADING THE NEEDLE, THE METAL NEEDLE PERFORATED THE PLASTIC TUBING AT THE END OF THE HUB. THIS REQUIRED THE INFANT TO REQUIRE MULTIPLE IV ATTEMPTS. THIS EQUIPMENT FAILURE RESULTED IN TWO UNSUCCESSFUL IV ATTEMPTS, CAUSING SKIN PUNCTURE TO THE BABY UNNECESSARILY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14956573 ↗
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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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