Jelco 3056Recalls & reported problems
Icu Medical, Inc. · GTIN for PRO 20 X 1 1/4 Each · Class 2
All models of Jelco (101)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10351688071101), received between Sep 17, 2019 and Aug 18, 2022 — classified as 1 injury, 2 malfunctions.
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
- Difficult or Delayed Separation1
- Difficult to Remove1
- Material Fragmentation1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2022Difficult to Remove; Difficult or Delayed Separation; Difficult to Remove; Difficult or Delayed Separation
IT WAS REPORTED THAT IT WAS DIFFICULT TO DISCONNECT CATHETER FROM INTRODUCER NEEDLE ONCE CATHETER IS IN VEIN. INTRODUCER NEEDLE NOT ALWAYS COVERED AFTER CATHETER WAS REMOVED. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER INFORMATION WAS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15249778 ↗MalfunctionApr 18, 2022Break; Break
IT WAS REPORTED THAT THE TIP OF CATHETER BROKE INSIDE OF A PATIENT. WE WERE ABLE TO REMOVE THE CATHETER, BUT NOT WITHOUT CAUSING EXTREME PAIN TO THE PATIENT.
Patient problems: Pain
MAUDE report 14137717 ↗InjurySep 17, 2019Material Fragmentation; Material Fragmentation
INFORMATION WAS RECEIVED INDICATING THAT UPON REMOVING A SMITHS MEDICAL JELCO® PROTECTIV® SAFETY I.V. CATHETER FROM THE PATIENT'S LEFT ARM, THE CATHETER WAS OBSERVED TO BE NOT ATTACHED. SUBSEQUENTLY, THE PATIENT HAD THE 3CM PIECE OF CATHETER SURGICALLY REMOVED. THERE WERE NO FURTHER ADVERSE EFFECTS.
Patient problems: Foreign Body In Patient
MAUDE report 9076023 ↗
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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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